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

Phase 2

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: DSXS1411; Drug: Placebo

• Registration Number: NCT02413229
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-09
• Primary Completion: 2015-09-14
• Study Completion: 2016-01-29
• Status Verified: 2018-11
• Results First Submitted: 2018-11-12
• Results First Submitted QC: 2018-11-12
• Last Update Submitted: 2018-11-12
• Results First Posted: 2018-12-06
• Last Update Posted: 2018-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DSXS1411	DSXS1411	DSXS applied once a day for a total of 28 days.
Placebo	Placebo	Placebo (vehicle) applied once a day for a total of 28 days.

Primary Outcome Measures

Name	Time	Method
Clinical Response of Success	28 Days	The proportion of patients in each treatment group that have clinical success at Day 28, which is defined by a Investigator's Global Assessment score of 0 or 1.