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Trial record 15 of 19 for:    "Secondary Adrenal Insufficiency" | "Respiratory System Agents"

Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02601469
Recruitment Status : Completed
First Posted : November 10, 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 Plaque Psoriasis
Intervention Drug: DSXS
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DSXS1503 Cohort 1 DSXS1503 Cohort 2
Hide Arm/Group Description

Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 19 years and older.

DSXS: twice daily for 28 days

Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 16-18 years of age.

DSXS: twice daily for 28 days

Period Title: Overall Study
Started 25 1
Completed 24 1
Not Completed 1 0
Reason Not Completed
Enrolled in Error             1             0
Arm/Group Title DSXS1503 Cohort 1 DSXS1503 Cohort 2 Total
Hide Arm/Group Description

Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 19 years and older.

DSXS: twice daily for 28 days

Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 16-18 years of age.

DSXS: twice daily for 28 days

Total of all reporting groups
Overall Number of Baseline Participants 25 1 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 1 participants 26 participants
56.72  (12.90) 17.00 55.19  (14.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 1 participants 26 participants
Female
10
  40.0%
1
 100.0%
11
  42.3%
Male
15
  60.0%
0
   0.0%
15
  57.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 1 participants 26 participants
Hispanic or Latino
25
 100.0%
1
 100.0%
26
 100.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
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 25 participants 1 participants 26 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
1
   4.0%
0
   0.0%
1
   3.8%
White
24
  96.0%
1
 100.0%
25
  96.2%
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 25 participants 1 participants 26 participants
2.11  (0.30) 1.83 2.10  (0.30)
Baseline IGA  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 1 participants 26 participants
Clear
0
   0.0%
0
   0.0%
0
   0.0%
Minimal
0
   0.0%
0
   0.0%
0
   0.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
20
  80.0%
1
 100.0%
21
  80.8%
Severe
5
  20.0%
0
   0.0%
5
  19.2%
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 DSXS1503 Cohort 1 DSXS1503 Cohort 2
Hide Arm/Group Description:

Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 19 years and older.

DSXS: twice daily for 28 days

Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 16-18 years of age.

DSXS: twice daily for 28 days

Overall Number of Participants Analyzed 24 1
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
3
  12.5%
0
   0.0%
No
21
  87.5%
1
 100.0%
Time Frame 1 year, 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DSXS1503 Cohort 1 DSXS1503 Cohort 2
Hide Arm/Group Description

Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 19 years and older.

DSXS: twice daily for 28 days

Administered twice daily for 28 days in patients with moderate to severe plaque psoriasis, age 16-18 years of age.

DSXS: twice daily for 28 days

All-Cause Mortality
DSXS1503 Cohort 1 DSXS1503 Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/1 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
DSXS1503 Cohort 1 DSXS1503 Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (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%
DSXS1503 Cohort 1 DSXS1503 Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/25 (28.00%)      0/1 (0.00%)    
Gastrointestinal disorders     
Abdominal pain  1  1/25 (4.00%)  1 0/1 (0.00%)  0
Diarrhoea  1  1/25 (4.00%)  1 0/1 (0.00%)  0
General disorders     
Application site irritation  1  1/25 (4.00%)  1 0/1 (0.00%)  0
Infections and infestations     
Nasopharyngitis  1  1/25 (4.00%)  1 0/1 (0.00%)  0
Investigations     
ACTH stimulation test abnormal  1  1/25 (4.00%)  1 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Bursitis  1  1/25 (4.00%)  1 0/1 (0.00%)  0
Nervous system disorders     
Headache  1  1/25 (4.00%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/25 (4.00%)  1 0/1 (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: NCT02601469     History of Changes
Other Study ID Numbers: DSXS 1503
First Submitted: November 1, 2015
First Posted: November 10, 2015
Results First Submitted: November 12, 2018
Results First Posted: December 7, 2018
Last Update Posted: December 7, 2018