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Trial record 61 of 740 for:    "Dermatitis, Atopic"

An Ascending Multiple Dose Study of VTP-38543 in Adult Participants With Mild to Moderate Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT02655679
Recruitment Status : Completed
First Posted : January 14, 2016
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Vitae Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dermatitis, Atopic
Interventions Drug: VTP-38543
Other: Vehicle with Transcutol®P
Other: Vehicle without Transcutol®P
Enrollment 104
Recruitment Details  
Pre-assignment Details  
Arm/Group Title VTP- 38543 0.05% VTP- 38543 0.15% Vehicle Without Transcutol®P VTP-38543 1% Vehicle With Transcutol®P
Hide Arm/Group Description VTP-38543 0.05% administered topically every 12 hours for 28 days. VTP-38543 0.15% administered topically every 12 hours for 28 days. Vehicle without Transcutol®P administered topically every 12 hours for 28 days. VTP-38543 1% administered topically every 12 hours for 28 days. Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
Period Title: Overall Study
Started 21 19 20 24 20
Received Study Drug (Safety Population) 20 19 20 24 20
Completed 18 16 19 20 19
Not Completed 3 3 1 4 1
Reason Not Completed
Adverse Event             0             1             0             0             0
Withdrawal by Subject             1             1             0             3             1
Inability to Comply with the Protocol             1             0             0             0             0
Lost to Follow-up             0             1             1             1             0
Other Miscellaneous Reasons             1             0             0             0             0
Arm/Group Title VTP- 38543 0.05% VTP- 38543 0.15% Vehicle Without Transcutol®P VTP-38543 1% Vehicle With Transcutol®P Total
Hide Arm/Group Description VTP-38543 0.05% administered topically every 12 hours for 28 days. VTP-38543 0.15% administered topically every 12 hours for 28 days. Vehicle without Transcutol®P administered topically every 12 hours for 28 days. VTP-38543 1% administered topically every 12 hours for 28 days. Vehicle with Transcutol®P administered topically every 12 hours for 28 days. Total of all reporting groups
Overall Number of Baseline Participants 20 19 20 24 20 103
Hide Baseline Analysis Population Description
Safety population included randomized participants who received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 19 participants 20 participants 24 participants 20 participants 103 participants
36.2  (15.79) 36.8  (13.39) 30.8  (11.59) 35.7  (10.51) 30.9  (11.73) 34.1  (12.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 20 participants 24 participants 20 participants 103 participants
Female
13
  65.0%
11
  57.9%
8
  40.0%
14
  58.3%
9
  45.0%
55
  53.4%
Male
7
  35.0%
8
  42.1%
12
  60.0%
10
  41.7%
11
  55.0%
48
  46.6%
1.Primary Outcome
Title Number of Participants With Treatment-related Adverse Events (AEs)
Hide Description An Adverse Event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The number of participants with AEs related to treatment are reported.
Time Frame Baseline (Day 0) to Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included randomized participants who received at least one dose of study medication.
Arm/Group Title VTP-38543 0.05% VTP-38543 0.15% Vehicle Without Transcutol®P VTP-38543 1% Vehicle With Transcutol®P
Hide Arm/Group Description:
VTP-38543 0.05% administered topically every 12 hours for 28 days.
VTP-38543 0.15% administered topically every 12 hours for 28 days.
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
VTP-38543 1% administered topically every 12 hours for 28 days.
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
Overall Number of Participants Analyzed 20 19 20 24 20
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.0%
3
  15.8%
2
  10.0%
6
  25.0%
2
  10.0%
2.Primary Outcome
Title Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
Hide Description Clinical Laboratory tests included chemistry, hematology and urinalysis tests collected during the study. The investigator determined if the changes in laboratory results were clinically significant.
Time Frame Baseline (Day 0) to Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included randomized participants who received at least one dose of study medication.
Arm/Group Title VTP-38543 0.05% VTP-38543 0.15% Vehicle Without Transcutol®P VTP-38543 1% Vehicle With Transcutol®P
Hide Arm/Group Description:
VTP-38543 0.05% administered topically every 12 hours for 28 days.
VTP-38543 0.15% administered topically every 12 hours for 28 days.
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
VTP-38543 1% administered topically every 12 hours for 28 days.
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
Overall Number of Participants Analyzed 20 19 20 24 20
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   5.3%
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Participants With Clinically Significant Changes in Vital Signs
Hide Description Vital signs included blood pressure, pulse, respiration rate and body temperature. The investigator determined if the changes in vital sign results were clinically significant.
Time Frame Baseline (Day 0) to Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included randomized participants who received at least one dose of study medication.
Arm/Group Title VTP-38543 0.05% VTP-38543 0.15% Vehicle Without Transcutol®P VTP-38543 1% Vehicle With Transcutol®P
Hide Arm/Group Description:
VTP-38543 0.05% administered topically every 12 hours for 28 days.
VTP-38543 0.15% administered topically every 12 hours for 28 days.
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
VTP-38543 1% administered topically every 12 hours for 28 days.
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
Overall Number of Participants Analyzed 20 19 20 24 20
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
Hide Description A standard 12-lead ECG was performed. The investigator determined if the changes in ECG results were clinically significant.
Time Frame Baseline (Day 0) to Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included randomized participants who received at least one dose of study medication.
Arm/Group Title VTP-38543 0.05% VTP-38543 0.15% Vehicle Without Transcutol®P VTP-38543 1% Vehicle With Transcutol®P
Hide Arm/Group Description:
VTP-38543 0.05% administered topically every 12 hours for 28 days.
VTP-38543 0.15% administered topically every 12 hours for 28 days.
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
VTP-38543 1% administered topically every 12 hours for 28 days.
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
Overall Number of Participants Analyzed 20 19 20 24 20
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) for VTP-38543-001
Hide Description [Not Specified]
Time Frame Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
Arm/Group Title VTP-38543 0.05% VTP-38543 0.15% VTP-38543 1%
Hide Arm/Group Description:
VTP-38543 0.05% administered topically every 12 hours for 28 days.
VTP-38543 0.15% administered topically every 12 hours for 28 days.
VTP-38543 1% administered topically every 12 hours for 28 days.
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
Day 0 Number Analyzed 6 participants 4 participants 6 participants
0.546  (1.16) 0.221  (0.175) 2.34  (3.29)
Day 27 Number Analyzed 5 participants 4 participants 4 participants
2.81  (5.35) 2.28  (1.68) 13.4  (12.7)
6.Secondary Outcome
Title Time to Maximum Plasma Concentrations (Tmax) for VTP-38543
Hide Description [Not Specified]
Time Frame Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
Arm/Group Title VTP-38543 0.05% VTP-38543 0.15% VTP-38543 1%
Hide Arm/Group Description:
VTP-38543 0.05% administered topically every 12 hours for 28 days.
VTP-38543 0.15% administered topically every 12 hours for 28 days.
VTP-38543 1% administered topically every 12 hours for 28 days.
Overall Number of Participants Analyzed 8 8 8
Median (Full Range)
Unit of Measure: hour
Day 0 Number Analyzed 6 participants 4 participants 6 participants
5.5
(2 to 9)
9
(2 to 9)
4
(2 to 9)
Day 27 Number Analyzed 5 participants 4 participants 4 participants
1
(0 to 4)
6.5
(2 to 24)
4
(4 to 9)
7.Secondary Outcome
Title Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUClast) for VTP-38543
Hide Description [Not Specified]
Time Frame Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
Arm/Group Title VTP-38543 0.05% VTP-38543 0.15% VTP-38543 1%
Hide Arm/Group Description:
VTP-38543 0.05% administered topically every 12 hours for 28 days.
VTP-38543 0.15% administered topically every 12 hours for 28 days.
VTP-38543 1% administered topically every 12 hours for 28 days.
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Day 0 Number Analyzed 6 participants 4 participants 6 participants
2.27  (4.23) 1.35  (1.41) 20.0  (28.2)
Day 27 Number Analyzed 5 participants 4 participants 4 participants
129  (257) 104  (77.5) 720  (798)
8.Secondary Outcome
Title Area Under the Plasma Concentration Versus Time Curve, From Time 0 to 12 Hours (AUC0-12hr) for VTP-38543
Hide Description [Not Specified]
Time Frame Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
Arm/Group Title VTP-38543 0.05% VTP-38543 0.15% VTP-38543 1%
Hide Arm/Group Description:
VTP-38543 0.05% administered topically every 12 hours for 28 days.
VTP-38543 0.15% administered topically every 12 hours for 28 days.
VTP-38543 1% administered topically every 12 hours for 28 days.
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Day 0 Number Analyzed 6 participants 4 participants 6 participants
2.27  (4.23) 1.35  (1.41) 20.0  (28.2)
Day 27 Number Analyzed 5 participants 4 participants 4 participants
23.6  (44.8) 22.2  (18.2) 144  (144)
9.Secondary Outcome
Title Elimination Half-life (t½) for VTP-38543
Hide Description [Not Specified]
Time Frame Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
Arm/Group Title VTP-38543 0.05% VTP-38543 0.15% VTP-38543 1%
Hide Arm/Group Description:
VTP-38543 0.05% administered topically every 12 hours for 28 days.
VTP-38543 0.15% administered topically every 12 hours for 28 days.
VTP-38543 1% administered topically every 12 hours for 28 days.
Overall Number of Participants Analyzed 8 8 8
Mean (Standard Deviation)
Unit of Measure: hour
Day 0 Number Analyzed 6 participants 4 participants 6 participants
NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
Day 27 Number Analyzed 5 participants 4 participants 4 participants
58.6  (14.5) 47.2  (12.2) 246  (349)
[1]
t1/2 was not achieved at Day 0.
10.Secondary Outcome
Title Percentage Change From Baseline in Total Body Surface Area (BSA)
Hide Description Percent BSA was estimated using the palmar surface of the participant’s hand up to the proximal interphalangeal joint, including the thumb, to approximate 1% of the participant’s BSA. The overall BSA affected by atopic dermatitis was evaluated from 0 to 100% and divided by 5 for a maximum of 20. A negative percentage change indicates improvement.
Time Frame Baseline (Day 0) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
Arm/Group Title VTP-38543 0.05% VTP-38543 0.15% Vehicle Without Transcutol®P VTP-38543 1% Vehicle With Transcutol®P
Hide Arm/Group Description:
VTP-38543 0.05% administered topically every 12 hours for 28 days.
VTP-38543 0.15% administered topically every 12 hours for 28 days.
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
VTP-38543 1% administered topically every 12 hours for 28 days.
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
Overall Number of Participants Analyzed 17 16 18 19 19
Mean (Standard Deviation)
Unit of Measure: percentage change in total BSA
-39.09  (29.233) -9.46  (52.978) -17.39  (55.588) -9.44  (48.063) -28.51  (29.398)
11.Secondary Outcome
Title Percentage Change From Baseline in Investigator Global Assessments (IGA) Score
Hide Description The investigator assessed the participant’s atopic dermatitis using the 5-point IGA where 0=clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting) to 4=Severe disease (Deep/bright red erythema with severe induration/papulation with oozing/crusting). A negative percentage change indicates improvement.
Time Frame Baseline (Day 0) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
Arm/Group Title VTP-38543 0.05% VTP-38543 0.15% Vehicle Without Transcutol®P VTP-38543 1% Vehicle With Transcutol®P
Hide Arm/Group Description:
VTP-38543 0.05% administered topically every 12 hours for 28 days.
VTP-38543 0.15% administered topically every 12 hours for 28 days.
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
VTP-38543 1% administered topically every 12 hours for 28 days.
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
Overall Number of Participants Analyzed 17 16 18 19 19
Mean (Standard Deviation)
Unit of Measure: percentage change in IGA score
-12.7  (25.36) -16.7  (34.96) -19.4  (32.46) -6.1  (34.79) -13.2  (20.47)
12.Secondary Outcome
Title Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
Hide Description The investigator assessed severity of atopic dermatitis (AD) using scoring atopic dermatitis (SCORAD) score obtained from different individual scales. 6-items: erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness were graded on a 4-point scale where 0=Absent to 3=Severe. The individual scores were added together to get a score of 0 to 18 that was multiplied by 3.5 for a score of 0 to 63. The overall BSA affected by AD (0 to 100 %) was divided by 5 for a score 0 to 20. The participant used a 10-point Visual Analog Scale (VAS) to evaluate loss of sleep and the occurrence of pruritus averaged over the last 3 days where 0=None to Worst Imaginable. The sum of the 2 VAS scores was 0 to 20. The above measures were added together for a total possible SCORAD score of 0 (best) to 103 (worst). A negative percentage change indicates improvement.
Time Frame Baseline (Day 0) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
Arm/Group Title VTP-38543 0.05% VTP-38543 0.15% Vehicle Without Transcutol®P VTP-38543 1% Vehicle With Transcutol®P
Hide Arm/Group Description:
VTP-38543 0.05% administered topically every 12 hours for 28 days.
VTP-38543 0.15% administered topically every 12 hours for 28 days.
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
VTP-38543 1% administered topically every 12 hours for 28 days.
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
Overall Number of Participants Analyzed 17 16 18 19 19
Mean (Standard Deviation)
Unit of Measure: percentage change in SCORAD score
-23.473  (30.1085) -17.300  (34.7270) -24.453  (35.6572) -14.483  (32.2743) -18.630  (26.0370)
13.Secondary Outcome
Title Percentage Change From Baseline Eczema Area and Severity Index (EASI)
Hide Description The investigator assessed four body regions: Head and neck, Upper extremities, Trunk including axillae and groin, and Lower extremities including buttocks. Each body region was scored based on BSA where 0=No involvement to 6=90-100%. Each body region was assessed for erythema, infiltration/papulation, excoriation and lichenification using a 4-point scale where 0=None to 3=Severe. EASI total score was determined by combining the individual scores for each of the 4 body regions. The total for each region was calculated by [erythema + infiltration+ excoriation + lichenification * area involvement * a constant (constants Head and Neck=0.1, Upper Limbs=0.2, Trunk=0.3, Lower Limbs=0.4)]. The EASI total score was determined by combining the individual scores for each of the 4 body regions for a total possible score of 0 (best) to 72 (worst). A negative percentage change indicates improvement.
Time Frame Baseline (Day 0) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
Arm/Group Title VTP-38543 0.05% VTP-38543 0.15% Vehicle Without Transcutol®P VTP-38543 1% Vehicle With Transcutol®P
Hide Arm/Group Description:
VTP-38543 0.05% administered topically every 12 hours for 28 days.
VTP-38543 0.15% administered topically every 12 hours for 28 days.
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
VTP-38543 1% administered topically every 12 hours for 28 days.
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
Overall Number of Participants Analyzed 17 16 18 19 19
Mean (Standard Deviation)
Unit of Measure: percentage change in EASI
-36.26  (29.832) -9.16  (66.519) -26.99  (46.549) -12.52  (58.819) -27.10  (36.323)
14.Secondary Outcome
Title Percentage Change From Baseline in Pruritus VAS Score
Hide Description The participant used a 10-point VAS to assess the occurrence of pruritus (itchy skin) over the last 3 days where 0= None to 10=Worst Imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.
Time Frame Baseline (Day 0) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
Arm/Group Title VTP-38543 0.05% VTP-38543 0.15% Vehicle Without Transcutol®P VTP-38543 1% Vehicle With Transcutol®P
Hide Arm/Group Description:
VTP-38543 0.05% administered topically every 12 hours for 28 days.
VTP-38543 0.15% administered topically every 12 hours for 28 days.
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
VTP-38543 1% administered topically every 12 hours for 28 days.
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
Overall Number of Participants Analyzed 17 16 18 19 19
Mean (Standard Deviation)
Unit of Measure: percentage change in pruritis VAS score
4.20  (112.105) -20.07  (48.771) -26.75  (47.715) -25.80  (42.232) -34.68  (54.612)
15.Secondary Outcome
Title Percentage Change From Baseline in VAS Sleep Score
Hide Description The participant used a 10-point VAS to evaluate loss of sleep averaged over the last 3 days where 0= None to 10=Worst imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.
Time Frame Baseline (Day 0) to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
Arm/Group Title VTP-38543 0.05% VTP-38543 0.15% Vehicle Without Transcutol®P VTP-38543 1% Vehicle With Transcutol®P
Hide Arm/Group Description:
VTP-38543 0.05% administered topically every 12 hours for 28 days.
VTP-38543 0.15% administered topically every 12 hours for 28 days.
Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
VTP-38543 1% administered topically every 12 hours for 28 days.
Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
Overall Number of Participants Analyzed 15 13 15 18 13
Mean (Standard Deviation)
Unit of Measure: percentage change in VAS sleep score
-29.40  (61.845) -19.74  (78.382) 2.73  (113.782) -29.98  (53.672) -30.85  (39.259)
Time Frame First dose of study drug to the last visit (Up to Day 35)
Adverse Event Reporting Description Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
 
Arm/Group Title VTP- 38543 0.05% VTP- 38543 0.15% Vehicle Without Transcutol®P VTP-38543 1% Vehicle With Transcutol®P
Hide Arm/Group Description VTP-38543 0.05% administered topically every 12 hours for 28 days. VTP-38543 0.15% administered topically every 12 hours for 28 days. Vehicle without Transcutol®P administered topically every 12 hours for 28 days. VTP-38543 1% administered topically every 12 hours for 28 days. Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
All-Cause Mortality
VTP- 38543 0.05% VTP- 38543 0.15% Vehicle Without Transcutol®P VTP-38543 1% Vehicle With Transcutol®P
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%)   0/20 (0.00%)   0/24 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
VTP- 38543 0.05% VTP- 38543 0.15% Vehicle Without Transcutol®P VTP-38543 1% Vehicle With Transcutol®P
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%)   0/20 (0.00%)   0/24 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VTP- 38543 0.05% VTP- 38543 0.15% Vehicle Without Transcutol®P VTP-38543 1% Vehicle With Transcutol®P
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/20 (50.00%)   12/19 (63.16%)   12/20 (60.00%)   8/24 (33.33%)   6/20 (30.00%) 
Blood and lymphatic system disorders           
Leukopenia  1  0/20 (0.00%)  0/19 (0.00%)  0/20 (0.00%)  1/24 (4.17%)  0/20 (0.00%) 
Endocrine disorders           
Hypothyroidism  1  1/20 (5.00%)  0/19 (0.00%)  0/20 (0.00%)  0/24 (0.00%)  0/20 (0.00%) 
Eye disorders           
Dry eye  1  0/20 (0.00%)  0/19 (0.00%)  0/20 (0.00%)  1/24 (4.17%)  0/20 (0.00%) 
Gastrointestinal disorders           
Diarrhoea  1  1/20 (5.00%)  0/19 (0.00%)  0/20 (0.00%)  0/24 (0.00%)  0/20 (0.00%) 
Dyspepsia  1  0/20 (0.00%)  1/19 (5.26%)  0/20 (0.00%)  0/24 (0.00%)  0/20 (0.00%) 
Tooth impacted  1  0/20 (0.00%)  1/19 (5.26%)  0/20 (0.00%)  0/24 (0.00%)  0/20 (0.00%) 
General disorders           
Application site pain  1  1/20 (5.00%)  1/19 (5.26%)  1/20 (5.00%)  3/24 (12.50%)  1/20 (5.00%) 
Application site pruritus  1  0/20 (0.00%)  1/19 (5.26%)  1/20 (5.00%)  1/24 (4.17%)  0/20 (0.00%) 
Administration site pruritus  1  1/20 (5.00%)  0/19 (0.00%)  0/20 (0.00%)  0/24 (0.00%)  0/20 (0.00%) 
Chest pain  1  1/20 (5.00%)  0/19 (0.00%)  0/20 (0.00%)  0/24 (0.00%)  0/20 (0.00%) 
Chills  1  0/20 (0.00%)  0/19 (0.00%)  1/20 (5.00%)  0/24 (0.00%)  0/20 (0.00%) 
Application site reaction  1  0/20 (0.00%)  0/19 (0.00%)  0/20 (0.00%)  2/24 (8.33%)  1/20 (5.00%) 
Fatigue  1  1/20 (5.00%)  0/19 (0.00%)  0/20 (0.00%)  1/24 (4.17%)  0/20 (0.00%) 
Chest discomfort  1  0/20 (0.00%)  0/19 (0.00%)  0/20 (0.00%)  0/24 (0.00%)  1/20 (5.00%) 
Infections and infestations           
Cellulitis  1  1/20 (5.00%)  0/19 (0.00%)  0/20 (0.00%)  0/24 (0.00%)  1/20 (5.00%) 
Post procedural infection  1  0/20 (0.00%)  1/19 (5.26%)  0/20 (0.00%)  0/24 (0.00%)  0/20 (0.00%) 
Upper respiratory tract infection  1  0/20 (0.00%)  1/19 (5.26%)  0/20 (0.00%)  0/24 (0.00%)  0/20 (0.00%) 
Nasopharyngitis  1  2/20 (10.00%)  3/19 (15.79%)  3/20 (15.00%)  1/24 (4.17%)  0/20 (0.00%) 
Body tinea  1  0/20 (0.00%)  0/19 (0.00%)  0/20 (0.00%)  1/24 (4.17%)  0/20 (0.00%) 
Otitis media acute  1  0/20 (0.00%)  0/19 (0.00%)  0/20 (0.00%)  1/24 (4.17%)  0/20 (0.00%) 
Injury, poisoning and procedural complications           
Procedural dizziness  1  1/20 (5.00%)  1/19 (5.26%)  0/20 (0.00%)  0/24 (0.00%)  0/20 (0.00%) 
Arthropod bite  1  0/20 (0.00%)  0/19 (0.00%)  0/20 (0.00%)  0/24 (0.00%)  1/20 (5.00%) 
Post procedural contusion  1  0/20 (0.00%)  0/19 (0.00%)  1/20 (5.00%)  0/24 (0.00%)  0/20 (0.00%) 
Sunburn  1  1/20 (5.00%)  0/19 (0.00%)  0/20 (0.00%)  0/24 (0.00%)  0/20 (0.00%) 
Ligament sprain  1  0/20 (0.00%)  1/19 (5.26%)  0/20 (0.00%)  0/24 (0.00%)  0/20 (0.00%) 
Investigations           
Aspartate aminotransferase increased  1  0/20 (0.00%)  1/19 (5.26%)  0/20 (0.00%)  0/24 (0.00%)  0/20 (0.00%) 
Blood creatine phosphokinase increased  1  0/20 (0.00%)  1/19 (5.26%)  0/20 (0.00%)  0/24 (0.00%)  0/20 (0.00%) 
Metabolism and nutrition disorders           
Decreased appetite  1  1/20 (5.00%)  0/19 (0.00%)  0/20 (0.00%)  0/24 (0.00%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/20 (0.00%)  0/19 (0.00%)  1/20 (5.00%)  0/24 (0.00%)  0/20 (0.00%) 
Back pain  1  0/20 (0.00%)  0/19 (0.00%)  0/20 (0.00%)  1/24 (4.17%)  0/20 (0.00%) 
Musculoskeletal pain  1  0/20 (0.00%)  1/19 (5.26%)  0/20 (0.00%)  0/24 (0.00%)  0/20 (0.00%) 
Nervous system disorders           
Headache  1  0/20 (0.00%)  1/19 (5.26%)  2/20 (10.00%)  1/24 (4.17%)  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders           
Oropharyngeal pain  1  0/20 (0.00%)  0/19 (0.00%)  1/20 (5.00%)  0/24 (0.00%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders           
Pruritus  1  2/20 (10.00%)  0/19 (0.00%)  1/20 (5.00%)  0/24 (0.00%)  0/20 (0.00%) 
Dermatitis atopic  1  0/20 (0.00%)  1/19 (5.26%)  0/20 (0.00%)  0/24 (0.00%)  1/20 (5.00%) 
Eczema  1  0/20 (0.00%)  1/19 (5.26%)  0/20 (0.00%)  0/24 (0.00%)  0/20 (0.00%) 
Urticaria  1  0/20 (0.00%)  0/19 (0.00%)  1/20 (5.00%)  0/24 (0.00%)  0/20 (0.00%) 
1
Term from vocabulary, MedDRA 18.1
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.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: Therapeutic Area, Head
Organization: Allergan
Phone: 714-246-4500
Responsible Party: Vitae Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02655679     History of Changes
Other Study ID Numbers: VTP-38543-001
First Submitted: January 11, 2016
First Posted: January 14, 2016
Results First Submitted: January 18, 2019
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019