Phase III Clinical Study in Patients With Mild to Severe Scalp Psoriasis
Phase 3
Completed
- Conditions
- Scalp Psoriasis
- Interventions
- Drug: DSXS topicalDrug: Vehicle topical
- Registration Number
- NCT02933866
- Lead Sponsor
- Taro Pharmaceuticals USA
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 371
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DSXS topical DSXS topical applied once daily for 28 days Vehicle topical Vehicle topical applied once daily for 28 days
- Primary Outcome Measures
Name Time Method Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success Day 29 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
Name Time Method
Trial Locations
- Locations (1)
Taro Pharmaceuticals USA, Inc.
🇺🇸Hawthorne, New York, United States