Back to resultsSafety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DSXS Topical product
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Male or non-pregnant, non-lactating females 18 years of age or older.
- IRE-approved, signed informed consent form that meets all criteria of current FDA regulations.
Exclusion Criteria:
- Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.
Sites / Locations
- Taro Pharmaceuticals USA, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dsxs topical product
Arm Description
treatment with DSXS once 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 stimulation
Secondary Outcome Measures
Full Information
NCT ID
NCT02933528
First Posted
October 11, 2016
Last Updated
November 12, 2018
Sponsor
Taro Pharmaceuticals USA
1. Study Identification
Unique Protocol Identification Number
NCT02933528
Brief Title
Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS
Official Title
An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS in Patients With Moderate to Severe Scalp Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 11, 2016 (Actual)
Primary Completion Date
August 11, 2017 (Actual)
Study Completion Date
November 27, 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 Maximal Use Treatment with DSXS .
Detailed Description
Evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe scalp psoriasis. Evaluate the efficacy parameters and adverse event (AE) profiles of DSXS topical product administered to patients with moderate to severe scalp psoriasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dsxs topical product
Arm Type
Experimental
Arm Description
treatment with DSXS once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
DSXS Topical product
Other Intervention Name(s)
Active
Intervention Description
once daily for 28 days
Primary Outcome Measure Information:
Title
Proportion of Patients in the Study With HPA Axis Suppression
Description
Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or non-pregnant, non-lactating females 18 years of age or older.
IRE-approved, signed informed consent form that meets all criteria of current FDA regulations.
Exclusion Criteria:
Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.
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
Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS
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