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

• ClinicalTrials.gov Identifier: NCT02932462
• Recruitment Status: Completed
• First Posted: October 13, 2016
• Results First Posted: December 6, 2018
• Last Update Posted: December 6, 2018
• Sponsor: Taro Pharmaceuticals USA
• Information provided by (Responsible Party): Taro Pharmaceuticals USA

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Scalp Psoriasis	Drug: DSXS; Drug: Placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 373 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: March 2016
• Actual Primary Completion Date: December 1, 2016
• Actual Study Completion Date: September 29, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: DSXS 1535; DSXS 1535 topical product	Drug: DSXS; topical product; Other Name: DSXS 1535
Placebo Comparator: Placebo; Vehicle	Drug: Placebo; topical product; Other Name: vehicle

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

Taro Pharmaceuticals USA

Investigators

• Study Chair: Novum Pharmaceutical Research Services; http://www.novumprs.com/contact
• Study Director: Natalie Yantovskiy; Taro Pharmaceuticals USA Inc.

More Information

• Responsible Party: Taro Pharmaceuticals USA
• ClinicalTrials.gov Identifier: NCT02932462
• Other Study ID Numbers: DSXS 1535
• First Posted: October 13, 2016
• Results First Posted: December 6, 2018
• Last Update Posted: December 6, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases