Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 19 for:    "Secondary Adrenal Insufficiency" | "Respiratory System Agents"

Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Atopic Dermatitis

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: NCT02595008
Recruitment Status : Completed
First Posted : November 3, 2015
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 Dermatitis, Atopic
Intervention Drug: DSXS
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DSXS Topical Product Cohort 1 DSXS Topical Product Cohort 2
Hide Arm/Group Description

treatment with DSXS twice daily for 28 days in patients age 18 years and older

DSXS: Active treatment

treatment with DSXS twice daily for 28 days in patients age 12-17 years of age

DSXS: Active treatment

Period Title: Overall Study
Started 20 4
Completed 19 4
Not Completed 1 0
Reason Not Completed
Enrolled In Error             1             0
Arm/Group Title DSXS Topical Product Cohort 1 DSXS Topical Product Cohort 2 Total
Hide Arm/Group Description

treatment with DSXS twice daily for 28 days in patients age 18 years and older

DSXS: Active treatment

treatment with DSXS twice daily for 28 days in patients age 12-17 years of age

DSXS: Active treatment

Total of all reporting groups
Overall Number of Baseline Participants 19 4 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 4 participants 23 participants
43.32  (11.18) 15.25  (2.36) 38.43  (14.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 4 participants 23 participants
Female
10
  52.6%
2
  50.0%
12
  52.2%
Male
9
  47.4%
2
  50.0%
11
  47.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 4 participants 23 participants
Hispanic or Latino
13
  68.4%
2
  50.0%
15
  65.2%
Not Hispanic or Latino
6
  31.6%
2
  50.0%
8
  34.8%
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 19 participants 4 participants 23 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
5
  26.3%
1
  25.0%
6
  26.1%
White
14
  73.7%
3
  75.0%
17
  73.9%
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 19 participants 4 participants 23 participants
2.03  (0.29) 1.78  (0.31) 1.98  (0.30)
Baseline IGA  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 4 participants 23 participants
Clear
0
   0.0%
0
   0.0%
0
   0.0%
Almost Clear
0
   0.0%
0
   0.0%
0
   0.0%
Mild Disease
0
   0.0%
0
   0.0%
0
   0.0%
Moderate Disease
17
  89.5%
2
  50.0%
19
  82.6%
Severe Disease
2
  10.5%
2
  50.0%
4
  17.4%
Eczema Area and Severity Index (EASI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 19 participants 4 participants 23 participants
19.74  (9.08) 28.50  (19.91) 21.26  (11.53)
[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 Number of Participants With HPA Axis Suppression
Hide Description Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml.
Time Frame 28 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DSXS Topical Product Cohort 1 DSXS Topical Product Cohort 2
Hide Arm/Group Description:

treatment with DSXS twice daily for 28 days in patients age 18 years and older

DSXS: Active treatment

treatment with DSXS twice daily for 28 days in patients age 12-17 years of age

DSXS: Active treatment

Overall Number of Participants Analyzed 19 4
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
3
  15.8%
1
  25.0%
No
16
  84.2%
3
  75.0%
Time Frame 1 year, 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DSXS Topical Product Cohort 1 DSXS Topical Product Cohort 2
Hide Arm/Group Description

treatment with DSXS twice daily for 28 days in patients age 18 years and older

DSXS: Active treatment

treatment with DSXS twice daily for 28 days in patients age 12-17 years of age

DSXS: Active treatment

All-Cause Mortality
DSXS Topical Product Cohort 1 DSXS Topical Product Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)      0/4 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
DSXS Topical Product Cohort 1 DSXS Topical Product Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/4 (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 Product Cohort 1 DSXS Topical Product Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/19 (21.05%)      0/4 (0.00%)    
Investigations     
ACTH stimulation test abnormal  1  3/19 (15.79%)  3 0/4 (0.00%)  0
Nervous system disorders     
Headache  1  1/19 (5.26%)  1 0/4 (0.00%)  0
1
Term from vocabulary, MedDRA (18.0)
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: NCT02595008     History of Changes
Other Study ID Numbers: DSXS 1502
First Submitted: November 1, 2015
First Posted: November 3, 2015
Results First Submitted: November 12, 2018
Results First Posted: December 7, 2018
Last Update Posted: December 7, 2018