A Randomized Double Blind Vehicle Controlled Dose Ranging Parallel Design Multiple Site Clinical Study

Taro Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: Placebo; Drug: DSXS1411

Study type: Interventional

Funder types: Industry

Identifiers

NCT02413229

DSXS 1411

Details and patient eligibility

About

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.

Full 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.

Enrollment: 151 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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151 participants in 2 patient groups, including a placebo group

DSXS1411

Experimental group

Description:

DSXS applied once a day for a total of 28 days.

Treatment:

Drug: DSXS1411

Placebo

Placebo Comparator group

Description:

Placebo (vehicle) applied once a day for a total of 28 days.

Treatment:

Drug: Placebo