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

Plaque Psoriasis Clinical Trial

Official title:

A Randomized Double Blind Vehicle Controlled Dose Ranging Multiple Site Phase 2 Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Moderate to Severe Scalp Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413229
• Other study ID #: DSXS 1411
• Status: Completed
• Phase: Phase 2
• Start date: April 2015
• Est. completion date: January 29, 2016

Study information

• Verified date: November 2018
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: January 29, 2016
• Est. primary completion date: September 14, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• DSXS1411
DSXS (Taro Pharmaceuticals Inc.)
• Placebo
Placebo (vehicle) (Taro Pharmaceuticals Inc.)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Response of Success	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.	28 Days