Back to resultsAn Open Label, Safety Study to Assess the Potential for Adrenal Suppression
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DSXS topical
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Male or non pregnant, non lactating females
Exclusion Criteria:
- Patients under 2 years of age
Sites / Locations
- Taro Pharmaceuticals USA Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DSXS topical
Arm Description
administered twice daily for 28 days
Outcomes
Primary Outcome Measures
Proportion of Patients in the Study With HPA Axis Suppression
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin
Secondary Outcome Measures
Full Information
NCT ID
NCT02932878
First Posted
October 12, 2016
Last Updated
November 12, 2018
Sponsor
Taro Pharmaceuticals USA
1. Study Identification
Unique Protocol Identification Number
NCT02932878
Brief Title
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression
Official Title
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS Topical Product in Patients With Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2, 2016 (Actual)
Primary Completion Date
April 10, 2017 (Actual)
Study Completion Date
October 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment with DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Plaque Psoriasis
Detailed Description
To evaluate the potential of DSXS to suppress HPA axis function in patients with mild to moderate plaque psoriasis.
To evaluate the efficacy parameters and adverse event (AE) profile of DSXS administered to patients with mild to moderate plaque psoriasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DSXS topical
Arm Type
Experimental
Arm Description
administered twice daily for 28 days
Intervention Type
Drug
Intervention Name(s)
DSXS topical
Other Intervention Name(s)
active
Intervention Description
topical treatment
Primary Outcome Measure Information:
Title
Proportion of Patients in the Study With HPA Axis Suppression
Description
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin
Time Frame
28 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or non pregnant, non lactating females
Exclusion Criteria:
Patients under 2 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novum Pharmaceutical Research Services
Organizational Affiliation
http://www.novumprs.com/contact
Official's Role
Study Chair
Facility Information:
Facility Name
Taro Pharmaceuticals USA Inc.
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression
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