Phase III Clinical Study in Patients With Mild to Severe Scalp Psoriasis

Taro Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Scalp Psoriasis

Treatments: Drug: DSXS topical; Drug: Vehicle topical

Study type: Interventional

Funder types: Industry

Identifiers

NCT02933866

DSXS 1536

Details and patient eligibility

About

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

Full 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.

Enrollment: 371 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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371 participants in 2 patient groups, including a placebo group

DSXS topical

Experimental group

Description:

applied once daily for 28 days

Treatment:

Drug: DSXS topical

Vehicle topical

Placebo Comparator group

Description:

applied once daily for 28 days

Treatment:

Drug: Vehicle topical