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

Scalp Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02933866
• Other study ID #: DSXS 1536
• Status: Completed
• Phase: Phase 3
• Start date: March 11, 2016
• Est. completion date: September 29, 2017

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: September 29, 2017
• Est. primary completion date: November 16, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Scalp Psoriasis

Intervention

Drug:
• DSXS topical
topical treatment
• Vehicle topical
topical treatment

Locations

Country	Name	City	State
United States	Taro Pharmaceuticals USA, Inc.	Hawthorne	New York

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success	Clinical Success is defined by an IGA score of 0 (clear) or I (almost clear) with at least a 2 grades reduction from baseline at Day 29 ± 2	Day 29