Back to resultsPhase III Clinical Study in Patients With Mild to Severe Scalp Psoriasis
Primary Purpose
Scalp Psoriasis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DSXS topical
Vehicle topical
Sponsored by
About this trial
This is an interventional treatment trial for Scalp Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Male or non-pregnant, non-lactating females 18 years of age and older.
Exclusion Criteria:
- Females who are pregnant, lactating or likely to become pregnant during the study.
Sites / Locations
- Taro Pharmaceuticals USA, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DSXS topical
Vehicle topical
Arm Description
applied once daily for 28 days
applied once daily for 28 days
Outcomes
Primary Outcome Measures
Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success
Clinical Success is defined by an IGA score of 0 (clear) or I (almost clear) with at least a 2 grades reduction from baseline at Day 29 ± 2
Secondary Outcome Measures
Full Information
NCT ID
NCT02933866
First Posted
October 12, 2016
Last Updated
November 12, 2018
Sponsor
Taro Pharmaceuticals USA
1. Study Identification
Unique Protocol Identification Number
NCT02933866
Brief Title
Phase III Clinical Study in Patients With Mild to Severe Scalp Psoriasis
Official Title
A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS Topical Product in Patients With Mild to Severe Scalp Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 11, 2016 (Actual)
Primary Completion Date
November 16, 2016 (Actual)
Study Completion Date
September 29, 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
A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS topical product in Patients with Mild to Severe Scalp Psoriasis
Detailed Description
To evaluate the therapeutic efficacy and safety of DSXS topical product (Taro Pharmaceuticals, U.S.A., Inc.) compared to a Vehicle topical product (Taro Pharmaceuticals, U.S.A., Inc.) in patients with mild to severe scalp psoriasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scalp Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
371 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DSXS topical
Arm Type
Experimental
Arm Description
applied once daily for 28 days
Arm Title
Vehicle topical
Arm Type
Placebo Comparator
Arm Description
applied once daily for 28 days
Intervention Type
Drug
Intervention Name(s)
DSXS topical
Other Intervention Name(s)
Active
Intervention Description
topical treatment
Intervention Type
Drug
Intervention Name(s)
Vehicle topical
Other Intervention Name(s)
placebo
Intervention Description
topical treatment
Primary Outcome Measure Information:
Title
Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success
Description
Clinical Success is defined by an IGA score of 0 (clear) or I (almost clear) with at least a 2 grades reduction from baseline at Day 29 ± 2
Time Frame
Day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or non-pregnant, non-lactating females 18 years of age and older.
Exclusion Criteria:
Females who are pregnant, lactating or likely to become pregnant during the study.
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
Phase III Clinical Study in Patients With Mild to Severe Scalp Psoriasis
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