A Randomized Double Blind Vehicle Controlled Dose Ranging Multiple Site Phase 2 Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Moderate to Severe Scalp Psoriasis
Overview
- Phase
- Phase 2
- Intervention
- DSXS1411
- Conditions
- Plaque Psoriasis
- Sponsor
- Taro Pharmaceuticals USA
- Enrollment
- 151
- Primary Endpoint
- Clinical Response of Success
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and a Placebo in patients with moderate to severe scalp psoriasis.
Detailed Description
This randomized, double-blind, vehicle-controlled, dose-ranging, parallel-group multi-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS, for the treatment of moderate to severe scalp psoriasis at different application times up to 30 minutes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or non-pregnant, non-lactating females age 12 and older.
- •Clinical diagnosis of moderate to severe scalp psoriasis, defined by a Investigator's Global Assessment score of at least 3 at screening.
Exclusion Criteria
- •Under 12 years of age.
- •Patients whose scalp and/or non-scalp psoriasis necessitates systemic or other concomitant topical therapies during the study.
- •Has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp.
Arms & Interventions
DSXS1411
DSXS applied once a day for a total of 28 days.
Intervention: DSXS1411
Placebo
Placebo (vehicle) applied once a day for a total of 28 days.
Intervention: Placebo
Outcomes
Primary Outcomes
Clinical Response of Success
Time Frame: 28 Days
The proportion of patients in each treatment group that have clinical success at Day 28, which is defined by a Investigator's Global Assessment score of 0 or 1.