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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: NCT02932891
Recruitment Status : Completed
First Posted : October 13, 2016
Results First Posted : December 7, 2018
Last Update Posted : December 7, 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 Atopic Dermatitis
Intervention Drug: DSXS topical
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DSXS Topical Cohort 1
Hide Arm/Group Description

active treatment

DSXS topical: topical treatment

Period Title: Overall Study
Started 28
Completed 24
Not Completed 4
Reason Not Completed
Lost to Follow-up             2
HPA Suppress             2
Arm/Group Title DSXS Topical Cohort 1
Hide Arm/Group Description

active treatment

DSXS topical: topical treatment

Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
14.36  (1.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
15
  53.6%
Male
13
  46.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Hispanic or Latino
20
  71.4%
Not Hispanic or Latino
8
  28.6%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
11
  39.3%
White
17
  60.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Baseline Total BSA  
Mean (Standard Deviation)
Unit of measure:  Meters squared
Number Analyzed 28 participants
1.61  (0.24)
Baseline IGA  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Clear
0
   0.0%
Minimal
0
   0.0%
Mild
0
   0.0%
Moderate Disease
17
  60.7%
Severe Disease
11
  39.3%
Eczema Area and Severity Index (EASI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 28 participants
17.64  (2.69)
[1]
Measure Description: The EASI is a composite score based on the severity of four different signs of atopic dermatitis (Erythema, Induration/Papulation/Edema, Lichenification, and Excoriation rated 0 to 3 in severity) in four different areas of the body (Head/Neck, Upper Limbs, Trunk, Lower Limbs) multiplied by the percent of that specific body area affected multiplied by a weighting factor. The minimum score would be 0 and the maximum score would be 72. To be eligible for participation in this study a patient must have an EASI of at least 15 at baseline. A higher EASI value represents a more severe case of eczema.
1.Primary Outcome
Title The Number of Patients in the Study With HPA Axis Suppression
Hide Description Hypothalamic Pituitary Adrenal (HPA) Axis Response to a stimulator
Time Frame 29 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DSXS Topical Cohort 1
Hide Arm/Group Description:

active treatment

DSXS topical: topical treatment

Overall Number of Participants Analyzed 17
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
8
  47.1%
No
9
  52.9%
Time Frame 8 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DSXS Topical Cohort 1
Hide Arm/Group Description

active treatment

DSXS topical: topical treatment

All-Cause Mortality
DSXS Topical Cohort 1
Affected / at Risk (%)
Total   0/28 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
DSXS Topical Cohort 1
Affected / at Risk (%) # Events
Total   0/28 (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
Affected / at Risk (%) # Events
Total   3/28 (10.71%)    
Infections and infestations   
Nasopharyngitis  1  1/28 (3.57%)  1
Musculoskeletal and connective tissue disorders   
Neck pain  1  1/28 (3.57%)  1
Nervous system disorders   
Headache  1  2/28 (7.14%)  2
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain  1  1/28 (3.57%)  1
1
Term from vocabulary, MedDRA (19.0)
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.
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: NCT02932891     History of Changes
Other Study ID Numbers: DSXS 1502a
First Submitted: October 12, 2016
First Posted: October 13, 2016
Results First Submitted: November 12, 2018
Results First Posted: December 7, 2018
Last Update Posted: December 7, 2018