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Completed

NCT Number: NCT02932462

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

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Key information

Conditions

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DSXS

Drug

topical product

Other names: DSXS 1535

Placebo

Drug

topical product

Other names: vehicle

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Oct 13, 2016
Registry last updated
Dec 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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