Study to Evaluate Efficacy and Safety of the Topical Product in Patients With Mild to Severe Scalp Psoriasis

Study Overview
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Brief Summary
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A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III Clinical Study

Detailed Description
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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

Official Title
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A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS 1535 in Patients With Mild to Severe Scalp Psoriasis

Conditions
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Scalp Psoriasis

Intervention / Treatment
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* Drug: DSXS
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DSXS 1535<br>DSXS 1535 topical product | Drug: DSXS<br>* topical product<br>* Other names: DSXS 1535;|
| Placebo Comparator: Placebo<br>Vehicle | Drug: Placebo<br>* topical product<br>* Other names: vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success in Patients With Moderate and Severe Scalp Psoriasis | IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline | from baseline to study day 29 | 
| Clinical Success in Patients With Mild to Severe Scalp Psoriasis | IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline | from baseline to study day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success in Patients With Mild Scalp Psoriasis | IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline | from baseline to study day 29 |