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

Taro Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Scalp Psoriasis

Treatments

Drug: Placebo

Drug: DSXS

Study type

Interventional

Funder types

Industry

Identifiers

NCT02932462

DSXS 1535

Details and patient eligibility

About

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

Full 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

Enrollment

373 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.