Study to Evaluate Efficacy and Safety of the Topical Product 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 1535 in Patients With Mild to Severe Scalp Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932462
• Other study ID #: DSXS 1535
• Status: Completed
• Phase: Phase 3
• Start date: March 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: September 29, 2017
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Scalp Psoriasis

Intervention

Drug:
• DSXS
topical product
• Placebo
topical product

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 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
Primary	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	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