Study to Evaluate Efficacy and Safety of the Topical Product in Patients With Mild to Severe Scalp Psoriasis

A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS 1535 in Patients With Mild to Severe Scalp Psoriasis

A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III Clinical Study

Study Overview

• Status: Completed
• Conditions: Scalp Psoriasis
• Intervention / Treatment: Drug: DSXS; Drug: Placebo

Detailed Description

This randomized, double-blind, vehicle-controlled, parallel-group multiple-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS 1535 product, for the treatment of mild to severe scalp psoriasis

• Study Type: Interventional
• Enrollment (Actual): 373
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with a clinical diagnosis of mild to severe plaque psoriasis of the scalp, defined by an Investigator's Global Assessment (IGA) score of at least 2 at baseline/randomization

Exclusion Criteria:

• Patients whose scalp psoriasis necessitates systemic or other concomitant topical therapies during the study (concomitant treatment of body psoriasis with over the counter topical products including emollients, is allowed).
• Patient has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp (e.g., seborrheic dermatitis, eczema, cutaneous T-cell lymphoma, or other forms of psoriasis including guttate, inverse, pustular or erythrodermic psoriasis)
• Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas that could interfere with the rating of efficacy parameters, including planned extensive exposure to sunlight during the study.
• History of psoriasis unresponsive to topical treatments.
• Current immunosuppression or history of organ transplant.
• Patients who have a history of or current diagnosis of glaucoma.
• Patients who have had surgery on the eyes or eyelids within 1 month before baseline or plan to have eye or eyelid surgery during the study.
• Patients with active infection (including but not limited to bacterial, fungal and viral infection) and/or open wounds on the entire head and neck area.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Vehicle	Drug: Placebo; topical product; Other Names: vehicle
Experimental: DSXS 1535; DSXS 1535 topical product	Drug: DSXS; topical product; Other Names: DSXS 1535

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success in Patients With Moderate and Severe Scalp Psoriasis	IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline	from baseline to study day 29
Clinical Success in Patients With Mild to Severe Scalp Psoriasis	IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline	from baseline to study day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success in Patients With Mild Scalp Psoriasis	IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline	from baseline to study day 29

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA
• Investigators: Study Director: Natalie Yantovskiy, Taro Pharmaceuticals USA Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): September 29, 2017

Study Registration Dates

• First Submitted: October 8, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (Estimate): October 13, 2016

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: DSXS 1535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No