Study to Evaluate Efficacy and Safety of the Topical Product in Patients With Mild to Severe Scalp Psoriasis
- Registration Number
- NCT02932462
- Lead Sponsor
- Taro Pharmaceuticals USA
- Brief Summary
A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III Clinical Study
- Detailed Description
This randomized, double-blind, vehicle-controlled, parallel-group multiple-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS 1535 product, for the treatment of mild to severe scalp psoriasis
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 373
Inclusion Criteria
- Patients with a clinical diagnosis of mild to severe plaque psoriasis of the scalp, defined by an Investigator's Global Assessment (IGA) score of at least 2 at baseline/randomization
Exclusion Criteria
- Patients whose scalp psoriasis necessitates systemic or other concomitant topical therapies during the study (concomitant treatment of body psoriasis with over the counter topical products including emollients, is allowed).
- Patient has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp (e.g., seborrheic dermatitis, eczema, cutaneous T-cell lymphoma, or other forms of psoriasis including guttate, inverse, pustular or erythrodermic psoriasis)
- Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas that could interfere with the rating of efficacy parameters, including planned extensive exposure to sunlight during the study.
- History of psoriasis unresponsive to topical treatments.
- Current immunosuppression or history of organ transplant.
- Patients who have a history of or current diagnosis of glaucoma.
- Patients who have had surgery on the eyes or eyelids within 1 month before baseline or plan to have eye or eyelid surgery during the study.
- Patients with active infection (including but not limited to bacterial, fungal and viral infection) and/or open wounds on the entire head and neck area.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Vehicle DSXS 1535 DSXS DSXS 1535 topical product
- Primary Outcome Measures
Name Time Method Clinical Success in Patients With Moderate and Severe Scalp Psoriasis from baseline to study day 29 IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
Clinical Success in Patients With Mild to Severe Scalp Psoriasis from baseline to study day 29 IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
- Secondary Outcome Measures
Name Time Method Clinical Success in Patients With Mild Scalp Psoriasis from baseline to study day 29 IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline