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Trial record 7 of 19 for:    "Secondary Adrenal Insufficiency" | "Respiratory System Agents"

An Open Label, Safety Study to Assess the Potential for Adrenal Suppression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02932878
Recruitment Status : Completed
First Posted : October 13, 2016
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Intervention Drug: DSXS topical
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DSXS Topical Cohort 1 DSXS Topical Cohort 2
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administered twice daily for 28 days in patients age 12-18 years of age

DSXS topical: topical treatment

administered twice daily for 28 days in patients age 6-11 years or age

DSXS topical: topical treatment

Period Title: Overall Study
Started 15 1
Completed 13 0
Not Completed 2 1
Reason Not Completed
Due to Lab Results             2             1
Arm/Group Title DSXS Topical Cohort 1 DSXS Topical Cohort 2 Total
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administered twice daily for 28 days in patients age 12-18 years of age

DSXS topical: topical treatment

administered twice daily for 28 days in patients age 6-11 years or age

DSXS topical: topical treatment

Total of all reporting groups
Overall Number of Baseline Participants 15 1 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 1 participants 16 participants
15.13  (1.88) 8.00 14.69  (2.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 1 participants 16 participants
Female
4
  26.7%
1
 100.0%
5
  31.3%
Male
11
  73.3%
0
   0.0%
11
  68.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 1 participants 16 participants
Hispanic or Latino
11
  73.3%
1
 100.0%
12
  75.0%
Not Hispanic or Latino
4
  26.7%
0
   0.0%
4
  25.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 1 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  13.3%
0
   0.0%
2
  12.5%
White
13
  86.7%
1
 100.0%
14
  87.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Total BSA  
Mean (Standard Deviation)
Unit of measure:  Meters squared
Number Analyzed 15 participants 1 participants 16 participants
1.86  (0.35) 1.31 1.83  (0.37)
Baseline IGA  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 1 participants 16 participants
Clear
0
   0.0%
0
   0.0%
0
   0.0%
Minimal
0
   0.0%
0
   0.0%
0
   0.0%
Mild
7
  46.7%
1
 100.0%
8
  50.0%
Moderate
8
  53.3%
0
   0.0%
8
  50.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Proportion of Patients in the Study With HPA Axis Suppression
Hide Description Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The one patient in Cohort 2 did not qualify for evaluation of HPA axis suppression.
Arm/Group Title DSXS Topical Cohort 1 DSXS Topical Cohort 2
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administered twice daily for 28 days in patients age 12-18 years of age

DSXS topical: topical treatment

administered twice daily for 28 days in patients age 6-11 years or age

DSXS topical: topical treatment

Overall Number of Participants Analyzed 11 0
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
1
   9.1%
0
No
10
  90.9%
0
Time Frame 8 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DSXS Topical Cohort 1 DSXS Topical Cohort 2
Hide Arm/Group Description

administered twice daily for 28 days in patients age 12-18 years of age

DSXS topical: topical treatment

administered twice daily for 28 days in patients age 6-11 years or age

DSXS topical: topical treatment

All-Cause Mortality
DSXS Topical Cohort 1 DSXS Topical Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
DSXS Topical Cohort 1 DSXS Topical Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DSXS Topical Cohort 1 DSXS Topical Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/1 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Natalie Yantovskiy
Organization: Taro Pharmaceuticals U.S.A. Inc
Phone: +1 914-345-9001 ext 6849
EMail: Natalie.Yantovskiy@Taro.com
Layout table for additonal information
Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02932878     History of Changes
Other Study ID Numbers: DSXS 1503a
First Submitted: October 12, 2016
First Posted: October 13, 2016
Results First Submitted: November 12, 2018
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018