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A Study to Evaluate Clinical Effect, Pharmacokinetics , Safety, and Tolerability of Umeclidinium in Palmar Hyperhidrosis Subjects

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ClinicalTrials.gov Identifier: NCT02673619
Recruitment Status : Completed
First Posted : February 4, 2016
Results First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hyperhidrosis
Interventions Drug: Umeclidinium
Drug: Vehicle
Enrollment 58
Recruitment Details This was a double blind, repeat dose, randomized, parallel group, placebo controlled study to examine the clinical effect, pharmacokinetics, safety and tolerability of topically applied umeclidinium (UMEC) for 28 days, to the palms, in participants with primary palmar hyperhidrosis. The study was conducted at six centers.
Pre-assignment Details Participants were randomized in 4:1 ratio (UMEC: vehicle) to receive UMEC 1.85 percent or vehicle in higher dose cohort and UMEC 1.15 percent or vehicle in lower dose cohort. A total of 140 participants were screened, of which 82 failed screening and 58 participants were randomized into the study.
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days. Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days. Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days. Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Period Title: Overall Study
Started 20 5 26 7
Completed 18 4 23 7
Not Completed 2 1 3 0
Reason Not Completed
Lost to Follow-up             1             0             0             0
Withdrawal by Subject             1             1             1             0
Adverse Event             0             0             1             0
Lack of Efficacy             0             0             1             0
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle) Total
Hide Arm/Group Description Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days. Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days. Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days. Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days. Total of all reporting groups
Overall Number of Baseline Participants 19 5 26 7 57
Hide Baseline Analysis Population Description
Safety Population: All participants who received study medication.
Age, Continuous   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Years
Cohort 1.85% Number Analyzed 19 participants 5 participants 0 participants 0 participants 24 participants
33.9  (12.31) 23.8  (4.09) 31.8  (11.79)
Cohort 1.15% Number Analyzed 0 participants 0 participants 26 participants 7 participants 33 participants
31.8  (10.45) 32.6  (12.55) 32.0  (10.72)
[1]
Measure Description: One participant was randomized but did not receive treatment.
[2]
Measure Analysis Population Description: Age has been presented in two different tables to provide total for higher and lower dose seperately
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 5 participants 26 participants 7 participants 57 participants
Female
14
  73.7%
3
  60.0%
14
  53.8%
5
  71.4%
36
  63.2%
Male
5
  26.3%
2
  40.0%
12
  46.2%
2
  28.6%
21
  36.8%
[1]
Measure Description: One participant was randomized but did not receive treatment
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race customized Number Analyzed 19 participants 5 participants 26 participants 7 participants 57 participants
AMERICAN INDIAN OR ALASKAN NATIVE
1
   5.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.8%
ASIAN (ASI)-CENTRAL/SOUTH ASI HERITAGE (HER)
1
   5.3%
0
   0.0%
1
   3.8%
0
   0.0%
2
   3.5%
BLACK OR AFRICAN AMERICAN
5
  26.3%
0
   0.0%
5
  19.2%
2
  28.6%
12
  21.1%
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
0
   0.0%
0
   0.0%
1
   3.8%
0
   0.0%
1
   1.8%
WHITE (W) ARABIC/NORTH AFRICAN HER
4
  21.1%
1
  20.0%
2
   7.7%
0
   0.0%
7
  12.3%
W-W/CAUCASIAN/EUROPEAN (EUR) HER
8
  42.1%
4
  80.0%
16
  61.5%
5
  71.4%
33
  57.9%
MULTIPLE-W-W/CAUCASIAN/EUR HER ASI - EAST ASI HER
0
   0.0%
0
   0.0%
1
   3.8%
0
   0.0%
1
   1.8%
[1]
Measure Description: One participant was randomized but did not receive treatment
1.Primary Outcome
Title Posterior Probability That the Response Rate is Greater Than 50%
Hide Description A response rate is defined as percentage of participants who achieved at least 30 percent decrease from Baseline in gravimetric sweat production at Day 29. Baseline was latest assessment prior to first dosing. A response rate of greater than 50 percent was considered to be clinically meaningful (greater than 50 percent of participants achieving at least 30 percent decrease from Baseline in gravimetric sweat production at Day 29). The posterior probability that response rate in sweat production is greater than 50 percent was analyzed. The evaluation was performed using Bayesian analysis, in which latest pre-dose value was used as Baseline.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was based on full analysis population comprised of all participants receiving study medication and having at least 1 non-missing change from Baseline efficacy assessment at/before Day 29.This analysis assessed whether response rate in UMEC arm exceeded a threshold that would warrant further development and is not relevant for vehicle.
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Lower Dose Cohort (UMEC 1.15 Percent)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 19 26
Measure Type: Number
Unit of Measure: Posterior Probability
1 0.9997
2.Primary Outcome
Title Percentage of Participants With at Least 30 Percent Reduction From Baseline in Sweat Production at Day 29
Hide Description Percentage of participants at Day 29 post-treatment with at least a 30 percent reduction from Baseline in sweat production measured by gravimetry. Participants remained at rest for at least 20-30 min before the measurements in order to reduce external interference. The latest pre-dose value was considered as Baseline value. The summary of percentage of participants from both the cohorts with at least 30 percent reduction from Baseline in sweat production was presented for the average of both palms.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 17 4 23 7
Measure Type: Number
Unit of Measure: Percentage of participants
100 75 82.6 57.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Higher Dose Cohort (UMEC 1.85 Percent), Higher Dose Cohort (Vehicle)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 25.0
Confidence Interval (2-Sided) 90%
-21.1 to 75.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lower Dose Cohort (UMEC 1.15 Percent), Lower Dose Cohort (Vehicle)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 25.5
Confidence Interval (2-Sided) 90%
-10.2 to 59.2
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With at Least 50% Reduction From Baseline in Sweat Production at Day 29
Hide Description Percentage of participants at Day 29 post-treatment with at least a 50 percent reduction from Baseline in sweat production was measured by gravimetric analysis. Participants remained at rest for at least 20-30 min before the measurements in order to reduce external interference. The latest pre-dose value was considered as Baseline value. The summary of percentage of participants from both the cohorts with at least 50 percent reduction from Baseline in sweat production was presented for the average of both palms.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 17 4 23 7
Measure Type: Number
Unit of Measure: Percentage of participants
58.8 75.0 60.9 42.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Higher Dose Cohort (UMEC 1.85 Percent), Higher Dose Cohort (Vehicle)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value -16.2
Confidence Interval (2-Sided) 90%
-59.7 to 32.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lower Dose Cohort (UMEC 1.15 Percent), Lower Dose Cohort (Vehicle)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 18.0
Confidence Interval (2-Sided) 90%
-18.8 to 52.1
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Amount of Sweat Produced at Day 29
Hide Description The amount of sweat produced was assessed by gravimetric measurement . Participants remained at rest for at least 20-30 min before the measurements in order to reduce external interference. Baseline value was the latest assessment prior to first dosing. The latest pre-dose value was considered as Baseline value.Change from Baseline value was calculated by post-dose visit value minus Baseline value. The summary of change from Baseline in sweat production has been presented for the average of both palms.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 17 4 23 7
Mean (Standard Deviation)
Unit of Measure: Milligrams (mg)
-129.5  (114.04) -124.8  (358.13) -137.5  (104.87) -112.4  (170.11)
5.Secondary Outcome
Title Percentage Change From Baseline/Day1 in Amount of Sweat Produced at Day 29
Hide Description The amount of sweat produced was assessed by gravimetric measurement . Participants remained at rest for at least 20-30 min before the measurements in order to reduce external interference. Baseline value was the latest assessment prior to first dosing. The latest pre-dose value was considered as Baseline value. Percentage change from Baseline was calculated with post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. The summary of percentage change from Baseline in sweat production was presented for the average of both palms.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 17 4 23 7
Mean (Standard Deviation)
Unit of Measure: Percentage change of sweat produced
-60.8  (20.80) -13.0  (113.79) -59.5  (26.42) -36.8  (44.88)
6.Secondary Outcome
Title Number of Participants With Shift of Response in HDSS Score at Day 29
Hide Description The HDSS was assessed based on a score 1 to 4 .The HDSS is a 4-point scale ranging from 1 (sweating never noticeable and never interferes daily activities), 2 (sweating tolerable but sometimes interferes daily activities), 3(sweating barely tolerable and frequently interferes daily activities) and 4 (sweating intolerable and always interferes daily activities s). A shift table describing change in response in participants from 1.85 percent cohort to 1.15 percent cohort has been presented for weekly average HDSS scores.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 17 4 23 7
Measure Type: Number
Unit of Measure: Participants
Score 1 to 1 0 0 0 0
Score 1 to 2 0 0 0 0
Score 1 to 3 0 0 0 0
Score 1 to 4 0 0 0 0
Score 2 to 1 0 0 0 0
Score 2 to 2 0 0 1 1
Score 2 to 3 0 0 0 1
Score 2 to 4 0 0 0 0
Score 3 to 1 2 0 0 0
Score 3 to 2 4 0 7 2
Score 3 to 3 2 0 5 1
Score 3 to 4 0 0 0 0
Score 4 to 1 0 0 1 0
Score 4 to 2 5 1 4 1
Score 4 to 3 1 2 0 0
Score 4 to 4 3 1 5 1
7.Secondary Outcome
Title Percentage of Participants With at Least 2-point Decrease From Baseline to Day 29 in HDSS Score
Hide Description The HDSS was assessed based on a score 1 to 4. The HDSS is a 4-point scale ranging from 1 (sweating never noticeable and never interferes daily activities), 2 (sweating tolerable but sometimes interferes daily activities), 3 (sweating barely tolerable and frequently interferes daily activities) and 4 (sweating intolerable and always interferes daily activities). Baseline value was the latest assessment prior to first dosing. The summary of percentage of participants from both the cohorts with at least 2-point decrease from Baseline in HDDS scores was presented.
Time Frame Baseline and Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 17 4 23 7
Measure Type: Number
Unit of Measure: Percentage of participants
41.20 25.0 21.7 14.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Higher Dose Cohort (UMEC 1.85 Percent), Higher Dose Cohort (Vehicle)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 16.2
Confidence Interval (2-Sided) 90%
-32.0 to 59.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lower Dose Cohort (UMEC 1.15 Percent), Lower Dose Cohort (Vehicle)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 7.5
Confidence Interval (2-Sided) 90%
-27.7 to 42.3
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Plasma Concentration After Repeat Dosing of UMEC
Hide Description Blood samples were collected at indicated time points. Samples were collected at nominal times relative to the proposed time of UMEC dosing. NA represents that the values were not available for specific arm or category. The participants with data available at specified time points were represented by n=x in the category titles.
Time Frame Pre dose on Day 27 and 28; 3, 6, 9, 10, 12, 16, 24 hours post dose on Day 29; 36 and 48 hours post dose on Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on pharmacokinetic concentration (PKCNC) Population , comprised of all participants in the Safety set for whom at least one pharmacokinetic sample was obtained and analyzed.
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Lower Dose Cohort (UMEC 1.15 Percent)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 12 22
Mean (Standard Deviation)
Unit of Measure: Picogram/milliliter (pg/mL)
DAY 27, PREDOSE, n=2,1 Number Analyzed 2 participants 1 participants
27.40  (23.052) 13.70 [1]   (NA)
DAY 28, PREDOSE, n=11,20 Number Analyzed 11 participants 20 participants
796.88  (2632.495) 267.19  (1176.936)
DAY 28, 3 H, n=12,19 Number Analyzed 12 participants 19 participants
0.00 [2]   (NA) 6.21  (10.197)
DAY 28, 6 H, n=12,18 Number Analyzed 12 participants 18 participants
2.07  (7.159) 10.56  (31.082)
DAY 28, 9 H, n=12,18 Number Analyzed 12 participants 18 participants
2.88  (6.883) 9.31  (33.097)
DAY 28, 10 H, n=11,18 Number Analyzed 11 participants 18 participants
8.07  (26.774) 1.54  (4.491)
DAY 28, 12 H, n=12,18 Number Analyzed 12 participants 18 participants
11.34  (39.289) 6.03  (25.597)
DAY 28, 16 H, n=12,18 Number Analyzed 12 participants 18 participants
24.50  (84.870) 2.08  (8.839)
DAY 28, 24 H, n=12,18 Number Analyzed 12 participants 18 participants
4.28  (14.809) 2.13  (9.027)
DAY 28, 36 H, n=12,18 Number Analyzed 12 participants 18 participants
2.03  (7.044) 0.93  (3.936)
DAY 28, 48 H, n=12,16 Number Analyzed 12 participants 16 participants
0.00 [2]   (NA) 10.94  (43.775)
[1]
Standard deviation could not be calculated for n =1.
[2]
Standard deviation could not be calculated since mean is zero.
9.Secondary Outcome
Title Maximum Plasma Concentration (Cmax)
Hide Description Blood samples were collected to measure Cmax at Day 28. Cmax is the maximum observed concentration, determined directly from the concentration-time data. The geometric mean and geometric coefficient were presented for all log transformed Cmax values.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
PKCNC Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Lower Dose Cohort (UMEC 1.15 Percent)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 9 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Log (pg/mL)
18.67
(401.89%)
10.31
(152.95%)
10.Secondary Outcome
Title Time of the Maximum Measured Plasma Concentration (Tmax) After Repeat Dosing of UMEC
Hide Description Blood samples were collected to measure Tmax at indicated time-points. Tmax is the time to reach Cmax, determined directly from the concentration-time data. Mean and standard deviation has been presented for Tmax values.
Time Frame Pre dose on Day 28; 3, 6, 9, 10, 12, 16, 24 hours post dose on Day 29; 36 and 48 hours post dose on Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
PKCNC Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Lower Dose Cohort (UMEC 1.15 Percent)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 4 7
Mean (Standard Deviation)
Unit of Measure: Hours
11.10  (4.287) 5.10  (2.905)
11.Secondary Outcome
Title The Terminal Plasma Elimination Rate Constant (Lambda z)
Hide Description Blood samples were planned to be collected to measure Lambda Z. The outcome measure was not analyzed due to lack of data availability.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
PKCNC Population. The terminal plasma elimination rate constant could not be derived for any of the participants included in the study because of insufficient data in the elimination phase.
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title The Apparent Terminal Phase Half-life (t1/2) After Repeat Dosing of UMEC
Hide Description Blood samples were planned to be collected to measure t1/2. The outcome measure was not analyzed due to lack of data availability.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
PKCNC Population. The terminal phase half-life could not be derived for any of the participants included in the study because of insufficient data in the elimination phase.
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title The Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] and AUC Over the Dosing Interval Tau, [AUC(0-tau)] After Repeat Dosing of UMEC
Hide Description Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) and AUC(0-tau) was calculated by the linear up and log down trapezoidal method. Samples were collected at nominal times relative to the proposed time of UMEC dosing. The participants with data available at specified time points were represented by n=x in the category titles.
Time Frame Pre dose on Day 28; 3, 6, 9, 10, 12, 16, 24 hours post dose on Day 29; 36 and 48 hours post dose on Day 30
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PKCNC Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Lower Dose Cohort (UMEC 1.15 Percent)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 12 22
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Log (h*pg/mL)
AUC(0-t), n=9,17 Number Analyzed 9 participants 17 participants
39.49
(648.14%)
21.87
(222.93%)
AUC(0-tau), n=6,11 Number Analyzed 6 participants 11 participants
964.71
(28.87%)
859.46
(0.00%)
14.Secondary Outcome
Title Plasma Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau)
Hide Description Trough (pre-dose at the end of each dosing interval) plasma concentration (Ctau) was analyzed at indicated time-points. Trough concentration samples were used for the assessment/attainment of steady state (ss). Samples were collected at nominal times relative to the proposed time of UMEC dosing. NA represents the data was not available for specific arm or category.
Time Frame Pre dose on Day 27 and 28; 3, 6, 9, 10, 12, 16, 24 hours post dose on Day 29; 36 and 48 hours post dose on Day 30
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PKCNC Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Lower Dose Cohort (UMEC 1.15 Percent)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mL
DAY 27;n=2,1 Number Analyzed 2 participants 1 participants
22.02
(124.80%)
13.70 [1] 
(NA%)
DAY 28;n=2,2 Number Analyzed 2 participants 2 participants
525.35
(270066.06%)
636.00
(8726.20%)
DAY 29;n=1,0 Number Analyzed 1 participants 0 participants
51.30 [1] 
(NA%)
[1]
Data was not available due to insufficient number of participants.
15.Secondary Outcome
Title Population Pharmacokinetic Profile After Repeat Dosing of UMEC
Hide Description Population pharmacokinetic profiling was planned to characterize the population pharmacokinetics of UMEC administered topically to both palms in participants with palmar hyperhidrosis. Due to the fact that the majority of the pharmacokinetic samples were below the limit of quantitation, a population pharmacokinetic analysis could not be performed.
Time Frame Pre dose on Day 27 and 28; 3, 6, 9, 10, 12, 16, 24 hours post dose on Day 29; 36 and 48 hours post dose on Day 30
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PKCNC Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Lower Dose Cohort (UMEC 1.15 Percent)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Number of Participants With Adverse Event (AE) and Serious Adverse Events (SAE's)
Hide Description An AE was any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was defined as any untoward medical occurrence that, that results in death, life-threatening, requires hospitalization or prolongation of existing hospitalization, disability/incapacity, any a congenital anomaly/birth defect or other situations at any dose.
Time Frame Up to Day 43
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This analysis was performed on safety population comprised of all participants who received study medication.
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 19 5 26 7
Measure Type: Number
Unit of Measure: Participants
Any AE 8 4 7 1
Any SAE 0 0 0 0
17.Secondary Outcome
Title Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Hide Description Single measurements of 12-lead ECGs were obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. ECG values were recorded as abnormal not clinically significant (NCS) and abnormal clinically significant (CS). The participants with data available at specified time points were represented by n=x in the category titles.
Time Frame Day 1, 15 and 29
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Safety Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 19 5 26 7
Measure Type: Number
Unit of Measure: Participants
Day 1; abnormal NCS; n=19,5,26,7 Number Analyzed 19 participants 5 participants 26 participants 7 participants
13 3 12 1
Day 1; abnormal CS; n=19,5,26,7 Number Analyzed 19 participants 5 participants 26 participants 7 participants
0 0 0 0
Day 15; abnormal NCS; n=19,4,23,7 Number Analyzed 19 participants 4 participants 23 participants 7 participants
12 2 9 1
Day 15; abnormal CS; n=19,4,23,7 Number Analyzed 19 participants 4 participants 23 participants 7 participants
0 0 0 0
Day 29; abnormal NCS; n=17,4,23,7 Number Analyzed 17 participants 4 participants 23 participants 7 participants
11 3 9 1
Day 29; abnormal CS; n=17,4,23,7 Number Analyzed 17 participants 4 participants 23 participants 7 participants
0 0 0 0
18.Secondary Outcome
Title Number of Participants With Abnormal Values of Hematological Parameters
Hide Description Blood samples were collected from participants for evaluation of hematology parameters by Potential Clinical Chemistry Criteria. The data was presented for only those hematology parameters for which abnormal values were found (neutrophils and hemoglobin) . During the analysis, no participant in the higher dose cohort- vehicle group, nor in the lower dose cohort (for both UMEC and vehicle groups) had abnormal hematology values that met the pre-specified criteria for potential clinical importance. Hence, the data for only higher dose cohort was presented. The measurements taken at Day 29 were presented. Participants were counted in the category for their values greater than (>) reference (ref) range high and less than (<) ref range low. The participants with data available at specified time points were represented by n=x in the category titles.
Time Frame Day 29
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Safety Population. This outcome measures the number of participants with abnormal values of hematological parameters, therefore, only the summary for the cohort/lab parameter with abnormal data at a certain time point was presented.
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 19 5
Measure Type: Number
Unit of Measure: Participants
Hemoglobin; > ref. range high;n=16,3 Number Analyzed 16 participants 3 participants
0 0
Hemoglobin; < ref. range low;n=16,3 Number Analyzed 16 participants 3 participants
1 0
Neutrophils; > ref.range high;n=16,3 Number Analyzed 16 participants 3 participants
0 0
Neutrophils; < ref.range low;n=16,3 Number Analyzed 16 participants 3 participants
1 0
19.Secondary Outcome
Title Number of Participants With Abnormal Values of Chemistry Parameters Assessment as a Safety Measure
Hide Description Blood samples were collected to analyze the abnormal clinical chemistry parameters by Potential Clinical Importance Criteria. The data was presented for only those parameters for which abnormal values were found (calcium, alanine aminotransferase [ALT]). Participants in the higher dose cohort (UMEC group) had abnormal calcium values and for ALT, the abnormal values were found in lower dose cohort (UMEC group). Hence, data was presented only for these specific cohorts. Participants were counted in the category for their values > ref range high and < ref range low. The measurements taken at Day 1, Day 15 and Day 29 were presented. The participants with data available at specified time points were represented by n=x in the category titles. "n=0" in category titles represents that the data was not available for participants in respective category or arm.
Time Frame Day 1, 15 and 29
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Safety Population. This outcome measures the number of participants with abnormal values of clinical chemistry parameters, therefore, only the summary for the cohort/lab parameter with abnormal data at a certain time point was presented.
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 19 5 26 7
Measure Type: Number
Unit of Measure: Participants
Calcium; Day 29; > ref. range high;n=17,4,0,0 Number Analyzed 17 participants 4 participants 0 participants 0 participants
0 0
Calcium; Day 29;< ref. range low;n=17,4,0,0 Number Analyzed 17 participants 4 participants 0 participants 0 participants
2 0
ALT; Day 1; > ref. range high;n=0,0,25,6 Number Analyzed 0 participants 0 participants 25 participants 6 participants
1 0
ALT; Day 1; < ref. range low;n=0,0,25,6 Number Analyzed 0 participants 0 participants 25 participants 6 participants
0 0
ALT; Day 15; > ref. range high; n=0,0,23,7 Number Analyzed 0 participants 0 participants 23 participants 7 participants
1 0
ALT; Day 15; < ref. range low; n=0,0,23,7 Number Analyzed 0 participants 0 participants 23 participants 7 participants
0 0
20.Secondary Outcome
Title Number of Participants With Abnormal Urine Analysis
Hide Description Urine sample were taken to analyze glucose and protein levels, blood and ketones body.Urinalysis analytes were measured by dipstick test. Results have been reported in a semi-quantitative manner as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations of the analyte in the urine sample. Abnormal laboratory values have been presented in the table. The participants with data available at specified time points were represented by n=x in the category titles.
Time Frame Day 1, 15 and 29
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Safety Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 19 5 26 7
Measure Type: Number
Unit of Measure: Participants
Day 1;Ketones;TRACE;n=19,5,25,7 Number Analyzed 19 participants 5 participants 25 participants 7 participants
1 0 1 1
Day 1;Ketones;1+;n=19,5,25,7 Number Analyzed 19 participants 5 participants 25 participants 7 participants
0 0 1 0
Day 1;Occult Blood;1+;n=19,5,25,7 Number Analyzed 19 participants 5 participants 25 participants 7 participants
0 0 0 1
Day 1;Occult Blood;2+;n=19,5,25,7 Number Analyzed 19 participants 5 participants 25 participants 7 participants
0 0 1 1
Day 1;Occult Blood;3+;n=19,5,25,7 Number Analyzed 19 participants 5 participants 25 participants 7 participants
0 0 1 1
Day 1;Protein;TRACE;n=19,5,25,7 Number Analyzed 19 participants 5 participants 25 participants 7 participants
2 1 2 0
DAY 15;Ketones;TRACE;n=19,4,23,7 Number Analyzed 19 participants 4 participants 23 participants 7 participants
2 0 0 1
DAY 15;Occult Blood;TRACE;n=19,4,23,7 Number Analyzed 19 participants 4 participants 23 participants 7 participants
0 0 1 0
DAY 15;Occult Blood;2+;n=19,4,23,7 Number Analyzed 19 participants 4 participants 23 participants 7 participants
0 0 1 0
DAY 15;Occult Blood;3+;n=19,4,23,7 Number Analyzed 19 participants 4 participants 23 participants 7 participants
2 0 0 1
DAY 15;Protein;1+;n=19,4,23,7 Number Analyzed 19 participants 4 participants 23 participants 7 participants
2 0 0 0
DAY 15;Protein;2+;n=19,4,23,7 Number Analyzed 19 participants 4 participants 23 participants 7 participants
1 0 0 0
DAY 29;Glucose;TRACE;n=16,3,22,7 Number Analyzed 16 participants 3 participants 22 participants 7 participants
0 0 1 0
DAY 29;Ketones;TRACE;n=16,3,22,7 Number Analyzed 16 participants 3 participants 22 participants 7 participants
0 0 1 1
DAY 29;Ketones;1+;n=16,3,22,7 Number Analyzed 16 participants 3 participants 22 participants 7 participants
1 0 0 0
DAY 29;Occult Blood;1+;n=16,3,22,7 Number Analyzed 16 participants 3 participants 22 participants 7 participants
0 0 2 0
DAY 29;Occult Blood;2+;n=16,3,22,7 Number Analyzed 16 participants 3 participants 22 participants 7 participants
1 0 1 1
DAY 29;Occult Blood;3+;n=16,3,22,7 Number Analyzed 16 participants 3 participants 22 participants 7 participants
1 0 0 1
DAY 29;Protein;TRACE;n=16,3,22,7 Number Analyzed 16 participants 3 participants 22 participants 7 participants
1 0 1 2
21.Secondary Outcome
Title Change From Baseline in Body Temperature Assessment as a Safety Measure
Hide Description Body temperature was measured as a vital sign in seated position, after 5 min rest. Baseline value was the latest assessment prior to first dosing. Change from Baseline value was calculated by post-dose visit value minus Baseline value. The participants with data available at specified time points were represented by n=x in the category titles.
Time Frame Baseline, Day 15, 27, 28 and 29
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Safety Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 19 5 26 7
Mean (Standard Deviation)
Unit of Measure: Celsius (C)
DAY 15, n=19,4,23,7 Number Analyzed 19 participants 4 participants 23 participants 7 participants
-0.11  (0.352) -0.20  (0.294) 0.14  (0.213) -0.09  (0.227)
DAY 27,n=12,3,18,7 Number Analyzed 12 participants 3 participants 18 participants 7 participants
-0.07  (0.287) -0.07  (0.462) 0.07  (0.277) -0.14  (0.162)
DAY 28,n=12,3,20,7 Number Analyzed 12 participants 3 participants 20 participants 7 participants
-0.03  (0.463) 0.07  (0.551) 0.05  (0.268) -0.09  (0.146)
DAY 29, n=17,4,23,7 Number Analyzed 17 participants 4 participants 23 participants 7 participants
0.08  (0.222) 0.15  (0.191) -0.04  (0.334) -0.11  (0.358)
22.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Hide Description Vital signs including SBP and DBP were measured in a seated position, after 5 minutes rest. Baseline value was the latest assessment prior to first dosing. Change from Baseline value was calculated by post-dose visit value minus Baseline value. The participants with data available at specified time points were represented by n=x in the category titles.
Time Frame Baseline, Day 15, 27, 28 and 29
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Safety Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 19 5 26 7
Mean (Standard Deviation)
Unit of Measure: Millimiters of mercury (mmHg)
DBP;Day 15; n=19,4,23,7 Number Analyzed 19 participants 4 participants 23 participants 7 participants
1.5  (6.79) 3.8  (5.68) -1.0  (5.83) 1.1  (12.40)
DBP;Day 27; n=12,3,18,7 Number Analyzed 12 participants 3 participants 18 participants 7 participants
-0.2  (4.75) -2.3  (12.42) -0.6  (11.08) 3.3  (6.50)
DBP;Day 28; n=12,3,20,7 Number Analyzed 12 participants 3 participants 20 participants 7 participants
-1.8  (7.12) 1.7  (12.58) 2.3  (7.25) 2.0  (7.16)
DBP;Day 29; n=17,4,23,7 Number Analyzed 17 participants 4 participants 23 participants 7 participants
-0.3  (5.64) -0.5  (8.27) 1.2  (8.41) 1.0  (9.64)
SBP;Day 15; n=19,4,23,7 Number Analyzed 19 participants 4 participants 23 participants 7 participants
1.2  (9.50) 3.5  (5.32) -7.0  (11.49) 0.1  (10.22)
SBP;Day 27; n=12,3,18,7 Number Analyzed 12 participants 3 participants 18 participants 7 participants
0.3  (12.41) -9.3  (11.37) -1.2  (11.12) 3.0  (8.31)
SBP;Day 28; n=12,3,20,7 Number Analyzed 12 participants 3 participants 20 participants 7 participants
-2.9  (12.44) -9.7  (20.21) 0.8  (8.65) 3.6  (10.52)
SBP;Day 29; n=17,4,23,7 Number Analyzed 17 participants 4 participants 23 participants 7 participants
1.5  (8.38) -2.0  (6.06) 1.0  (10.65) -2.4  (7.07)
23.Secondary Outcome
Title Change From Baseline in Heart Rate
Hide Description Heart rate was measured in a seated position, after 5 minutes rest. Baseline value was the latest assessment prior to first dosing. Change from Baseline value was calculated by post-dose visit value minus Baseline value. The participants with data available at specified time points were represented by n=x in the category titles.
Time Frame Baseline, Day 15, 27, 28 and 29
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Safety Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 19 5 26 7
Mean (Standard Deviation)
Unit of Measure: Beats/minute (min)
Heart rate; Day15;n=19,4,23,7 Number Analyzed 19 participants 4 participants 23 participants 7 participants
0.4  (6.57) -3.8  (6.85) 0.3  (6.43) -1.7  (9.84)
Heart rate;Day 27;n=12,3,18,7 Number Analyzed 12 participants 3 participants 18 participants 7 participants
-1.6  (9.55) -2.0  (4.00) 0.2  (7.73) 0.4  (6.68)
Heart rate;Day 28;n=12,3,20,7 Number Analyzed 12 participants 3 participants 20 participants 7 participants
4.3  (12.32) 1.7  (10.02) 3.4  (9.46) -1.1  (12.17)
Heart rate;Day 29;n=17,4,23,7 Number Analyzed 17 participants 4 participants 23 participants 7 participants
-1.0  (8.05) -1.0  (3.46) -0.3  (10.19) -6.3  (12.22)
24.Secondary Outcome
Title Change From Baseline in Weight
Hide Description Weight measurement was performed as a measure of safety. Baseline value was the latest assessment prior to first dosing. Change from Baseline value was calculated by post-dose visit value minus Baseline value.
Time Frame Baseline and Up to Day 29
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Safety Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 17 4 23 7
Mean (Standard Deviation)
Unit of Measure: Kilograms (Kg)
0.51  (1.892) -0.10  (0.392) 0.83  (2.919) -2.67  (5.113)
25.Secondary Outcome
Title Number of Participants With Local Tolerability Assessments
Hide Description Skin tolerability was assessed by a 5-point tolerability scale ranging from 0 to 4; where 0 (no irritation), 1 (mild), 2 (moderate), 3 (severe) to 4 (Very Severe).The participants with data available at specified time points were represented by n=x in the category titles.
Time Frame Day 1, 8, 15, 22, 27, 28, 29, 30, 36 and 43
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Safety Population
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description:
Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
Overall Number of Participants Analyzed 19 5 26 7
Measure Type: Number
Unit of Measure: Participants
Day 1;no irritation;n=19,5,26,7 Number Analyzed 19 participants 5 participants 26 participants 7 participants
19 5 26 7
Day 1; mild;n=19,5,26,7 Number Analyzed 19 participants 5 participants 26 participants 7 participants
0 0 0 0
Day 1; moderate;n=19,5,26,7 Number Analyzed 19 participants 5 participants 26 participants 7 participants
0 0 0 0
Day 1; Severe;n=19,5,26,7 Number Analyzed 19 participants 5 participants 26 participants 7 participants
0 0 0 0
Day 1; Very Severe;n=19,5,26,7 Number Analyzed 19 participants 5 participants 26 participants 7 participants
0 0 0 0
Day 8 ;no irritation;n=19,4,25,7 Number Analyzed 19 participants 4 participants 25 participants 7 participants
16 4 24 6
Day 8 ;mild;n=19,4,25,7 Number Analyzed 19 participants 4 participants 25 participants 7 participants
3 0 1 1
Day 8 ;moderate;n=19,4,25,7 Number Analyzed 19 participants 4 participants 25 participants 7 participants
0 0 0 0
Day 8 ;Severe;n=19,4,25,7 Number Analyzed 19 participants 4 participants 25 participants 7 participants
0 0 0 0
Day 8 ;Very Severe;n=19,4,25,7 Number Analyzed 19 participants 4 participants 25 participants 7 participants
0 0 0 0
Day15;no irritation;n=19,4,22,7 Number Analyzed 19 participants 4 participants 22 participants 7 participants
18 4 22 7
Day 15 ;mild;n=19,4,22,7 Number Analyzed 19 participants 4 participants 22 participants 7 participants
1 0 0 0
Day 15 ;moderate;n=19,4,22,7 Number Analyzed 19 participants 4 participants 22 participants 7 participants
0 0 0 0
Day 15 ;Severe;n=19,4,22,7 Number Analyzed 19 participants 4 participants 22 participants 7 participants
0 0 0 0
Day 15 ;Very Severe;n=19,4,22,7 Number Analyzed 19 participants 4 participants 22 participants 7 participants
0 0 0 0
Day 22 ;no irritation;n=18,4,23,7 Number Analyzed 18 participants 4 participants 23 participants 7 participants
16 4 22 7
Day 22 ;mild;n=18,4,23,7 Number Analyzed 18 participants 4 participants 23 participants 7 participants
2 0 1 0
Day 22 ;moderate;n=18,4,23,7 Number Analyzed 18 participants 4 participants 23 participants 7 participants
0 0 0 0
Day 22 ;Severe;n=18,4,23,7 Number Analyzed 18 participants 4 participants 23 participants 7 participants
0 0 0 0
Day 22 ;Very Severe;n=18,4,23,7 Number Analyzed 18 participants 4 participants 23 participants 7 participants
0 0 0 0
Day 27 ;no irritation;n=12,3,18,7 Number Analyzed 12 participants 3 participants 18 participants 7 participants
12 1 17 7
Day 27 ;mild;n=12,3,18,7 Number Analyzed 12 participants 3 participants 18 participants 7 participants
0 2 1 0
Day 27 ;moderate;n=12,3,18,7 Number Analyzed 12 participants 3 participants 18 participants 7 participants
0 0 0 0
Day 27 ;Severe;n=12,3,18,7 Number Analyzed 12 participants 3 participants 18 participants 7 participants
0 0 0 0
Day 27 ;Very Severe;n=12,3,18,7 Number Analyzed 12 participants 3 participants 18 participants 7 participants
0 0 0 0
Day 28 ;no irritation;n=12,3,20,7 Number Analyzed 12 participants 3 participants 20 participants 7 participants
11 3 19 7
Day 28 ;mild;n=12,3,20,7 Number Analyzed 12 participants 3 participants 20 participants 7 participants
1 0 1 0
Day 28 ;moderate;n=12,3,20,7 Number Analyzed 12 participants 3 participants 20 participants 7 participants
0 0 0 0
Day 28 ;Severe;n=12,3,20,7 Number Analyzed 12 participants 3 participants 20 participants 7 participants
0 0 0 0
Day 28 ;Very Severe;n=12,3,20,7 Number Analyzed 12 participants 3 participants 20 participants 7 participants
0 0 0 0
Day 29 ;no irritation;n=17,4,23,7 Number Analyzed 17 participants 4 participants 23 participants 7 participants
15 4 23 6
Day 29 ;mild;n=17,4,23,7 Number Analyzed 17 participants 4 participants 23 participants 7 participants
2 0 0 1
Day 29 ;moderate;n=17,4,23,7 Number Analyzed 17 participants 4 participants 23 participants 7 participants
0 0 0 0
Day 29 ;Severe;n=17,4,23,7 Number Analyzed 17 participants 4 participants 23 participants 7 participants
0 0 0 0
Day 29 ;Very Severe;n=17,4,23,7 Number Analyzed 17 participants 4 participants 23 participants 7 participants
0 0 0 0
Day 30 ;no irritation;n=12,3,18,7 Number Analyzed 12 participants 3 participants 18 participants 7 participants
12 3 17 7
Day 30 ;mild;n=12,3,18,7 Number Analyzed 12 participants 3 participants 18 participants 7 participants
0 0 1 0
Day 30 ;moderate;n=12,3,18,7 Number Analyzed 12 participants 3 participants 18 participants 7 participants
0 0 0 0
Day 30 ;Severe;n=12,3,18,7 Number Analyzed 12 participants 3 participants 18 participants 7 participants
0 0 0 0
Day 30 ;Very Severe;n=12,3,18,7 Number Analyzed 12 participants 3 participants 18 participants 7 participants
0 0 0 0
Day 36; no irritation;n=18,3,23,7 Number Analyzed 18 participants 3 participants 23 participants 7 participants
16 3 23 7
Day 36 ;mild;n=18,3,23,7 Number Analyzed 18 participants 3 participants 23 participants 7 participants
1 0 0 0
Day 36 ;moderate;n=18,3,23,7 Number Analyzed 18 participants 3 participants 23 participants 7 participants
1 0 0 0
Day 36 ;Severe;n=18,3,23,7 Number Analyzed 18 participants 3 participants 23 participants 7 participants
0 0 0 0
Day 36 ;Very Severe;n=18,3,23,7 Number Analyzed 18 participants 3 participants 23 participants 7 participants
0 0 0 0
Day 43 ;no irritation;n=18,4,23,7 Number Analyzed 18 participants 4 participants 23 participants 7 participants
17 4 23 6
Day 43 ;mild;n=18,4,23,7 Number Analyzed 18 participants 4 participants 23 participants 7 participants
1 0 0 1
Day 43 ;moderate;n=18,4,23,7 Number Analyzed 18 participants 4 participants 23 participants 7 participants
0 0 0 0
Day 43 ;Severe;n=18,4,23,7 Number Analyzed 18 participants 4 participants 23 participants 7 participants
0 0 0 0
Day 43 ;Very Severe;n=18,4,23,7 Number Analyzed 18 participants 4 participants 23 participants 7 participants
0 0 0 0
Time Frame On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment until the follow up (up to Day 43).
Adverse Event Reporting Description AEs and SAEs were collected in safety population comprised of all participants who received study medication.
 
Arm/Group Title Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Hide Arm/Group Description Participants applied UMEC 1.85 percent solution topically once a day (2 microliter [µL]/centimeter [cm]^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days. Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days. Participants received UMEC 1.15 percent solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days. Participants received vehicle solution applied topically once a day (2 µL/cm^2) to both the hands (palm and fingers) using graduated syringe at night before bedtime for 28 days.
All-Cause Mortality
Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/5 (0.00%)   0/26 (0.00%)   0/7 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/5 (0.00%)   0/26 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Higher Dose Cohort (UMEC 1.85 Percent) Higher Dose Cohort (Vehicle) Lower Dose Cohort (UMEC 1.15 Percent) Lower Dose Cohort (Vehicle)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/19 (42.11%)   4/5 (80.00%)   7/26 (26.92%)   1/7 (14.29%) 
Blood and lymphatic system disorders         
Anaemia  1  1/19 (5.26%)  0/5 (0.00%)  0/26 (0.00%)  0/7 (0.00%) 
Gastrointestinal disorders         
Toothache  1  1/19 (5.26%)  0/5 (0.00%)  0/26 (0.00%)  0/7 (0.00%) 
Abdominal discomfort  1  0/19 (0.00%)  1/5 (20.00%)  0/26 (0.00%)  0/7 (0.00%) 
Diarrhoea  1  0/19 (0.00%)  1/5 (20.00%)  0/26 (0.00%)  0/7 (0.00%) 
Vomiting  1  0/19 (0.00%)  1/5 (20.00%)  1/26 (3.85%)  0/7 (0.00%) 
General disorders         
Administration site pruritus  1  1/19 (5.26%)  0/5 (0.00%)  0/26 (0.00%)  0/7 (0.00%) 
Administration site swelling  1  1/19 (5.26%)  0/5 (0.00%)  0/26 (0.00%)  0/7 (0.00%) 
Application site dryness  1  1/19 (5.26%)  0/5 (0.00%)  0/26 (0.00%)  0/7 (0.00%) 
Application site hypoaesthesia  1  1/19 (5.26%)  0/5 (0.00%)  0/26 (0.00%)  0/7 (0.00%) 
Application site paraesthesia  1  1/19 (5.26%)  0/5 (0.00%)  0/26 (0.00%)  0/7 (0.00%) 
Application site pain  1  0/19 (0.00%)  0/5 (0.00%)  1/26 (3.85%)  0/7 (0.00%) 
Immune system disorders         
Seasonal allergy  1  0/19 (0.00%)  0/5 (0.00%)  1/26 (3.85%)  0/7 (0.00%) 
Infections and infestations         
Nasopharyngitis  1  3/19 (15.79%)  1/5 (20.00%)  0/26 (0.00%)  0/7 (0.00%) 
Upper respiratory tract infection  1  1/19 (5.26%)  0/5 (0.00%)  1/26 (3.85%)  0/7 (0.00%) 
Injury, poisoning and procedural complications         
Muscle strain  1  0/19 (0.00%)  1/5 (20.00%)  0/26 (0.00%)  0/7 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  0/19 (0.00%)  0/5 (0.00%)  1/26 (3.85%)  0/7 (0.00%) 
Nervous system disorders         
Headache  1  2/19 (10.53%)  1/5 (20.00%)  2/26 (7.69%)  1/7 (14.29%) 
Reproductive system and breast disorders         
Dysmenorrhoea  1  0/19 (0.00%)  0/5 (0.00%)  0/26 (0.00%)  1/7 (14.29%) 
Respiratory, thoracic and mediastinal disorders         
Sinus congestion  1  0/19 (0.00%)  0/5 (0.00%)  1/26 (3.85%)  0/7 (0.00%) 
Skin and subcutaneous tissue disorders         
Onychoclasis  1  0/19 (0.00%)  1/5 (20.00%)  0/26 (0.00%)  0/7 (0.00%) 
Vascular disorders         
Neurogenic shock  1  1/19 (5.26%)  0/5 (0.00%)  0/26 (0.00%)  0/7 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT02673619     History of Changes
Other Study ID Numbers: 201484
First Submitted: January 25, 2016
First Posted: February 4, 2016
Results First Submitted: November 22, 2017
Results First Posted: February 9, 2018
Last Update Posted: February 9, 2018