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Trial record 9 of 19 for:    "Secondary Adrenal Insufficiency" | "Respiratory System Agents"

Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS

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ClinicalTrials.gov Identifier: NCT02933528
Recruitment Status : Completed
First Posted : October 14, 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 Psoriasis
Intervention Drug: DSXS Topical product
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dsxs Topical Product
Hide Arm/Group Description

treatment with DSXS once daily for 28 days

DSXS Topical product: once daily for 28 days

Period Title: Overall Study
Started 24
Completed 22
Not Completed 2
Reason Not Completed
Lost to Follow-up             2
Arm/Group Title Dsxs Topical Product
Hide Arm/Group Description

treatment with DSXS once daily for 28 days

DSXS Topical product: once daily for 28 days

Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
48.8  (17.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
16
  69.6%
Male
7
  30.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Hispanic or Latino
12
  52.2%
Not Hispanic or Latino
11
  47.8%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   4.3%
Black or African American
3
  13.0%
White
19
  82.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Percent Scalp Affected with Plaque Psoriasis  
Mean (Standard Deviation)
Unit of measure:  Percent of scalp
Number Analyzed 23 participants
42.2  (22.6)
1.Primary Outcome
Title Proportion of Patients in the Study With HPA Axis Suppression
Hide Description Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dsxs Topical Product
Hide Arm/Group Description:

treatment with DSXS once daily for 28 days

DSXS Topical product: once daily for 28 days

Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
1
   7.1%
No
13
  92.9%
Time Frame 1 year, 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dsxs Topical Product
Hide Arm/Group Description

treatment with DSXS once daily for 28 days

DSXS Topical product: once daily for 28 days

All-Cause Mortality
Dsxs Topical Product
Affected / at Risk (%)
Total   0/23 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Dsxs Topical Product
Affected / at Risk (%) # Events
Total   1/23 (4.35%)    
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous  1  1/23 (4.35%)  1
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
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
Affected / at Risk (%) # Events
Total   6/23 (26.09%)    
Eye disorders   
Conjunctival haemorrhage  1  1/23 (4.35%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/23 (4.35%)  1
Nausea  1  1/23 (4.35%)  1
Vomiting  1  1/23 (4.35%)  1
General disorders   
Application site alopecia  1  1/23 (4.35%)  1
Chest pain  1  1/23 (4.35%)  1
Injury, poisoning and procedural complications   
Chemical burn of skin  1  1/23 (4.35%)  1
Nervous system disorders   
Headache  1  1/23 (4.35%)  1
Sinus headache  1  1/23 (4.35%)  1
Pregnancy, puerperium and perinatal conditions   
Pregnancy  1  1/23 (4.35%)  1
Reproductive system and breast disorders   
Dysmenorrhoea  1  1/23 (4.35%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/23 (4.35%)  1
Oropharyngeal pain  1  2/23 (8.70%)  2
Respiratory tract congestion  1  1/23 (4.35%)  2
Rhinorrhoea  1  1/23 (4.35%)  1
1
Term from vocabulary, MedDRA (19.1)
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.
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: NCT02933528     History of Changes
Other Study ID Numbers: DSXS 1538a
First Submitted: October 11, 2016
First Posted: October 14, 2016
Results First Submitted: November 12, 2018
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018