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

NCT02932462 | Completed Phase 3 Results FDA Drug

• 1 other identifier: DSXS 1535
• Study Type: interventional
• Target: 373
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Scalp Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Clinical Success in Patients With Mild Scalp Psoriasis

  from baseline to study day 29

Study Arms (2)

DSXS 1535

EXPERIMENTAL

DSXS 1535 topical product

Drug: DSXS

Placebo

PLACEBO COMPARATOR

Vehicle

Drug: Placebo

Interventions

DSXS DRUG

topical product

Also known as: DSXS 1535

DSXS 1535

Placebo DRUG

topical product

Also known as: vehicle

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Results Point of Contact

• Title: Natalie Yantovskiy
• Organization: Taro Pharmaceuticals U.S.A. Inc

Natalie.Yantovskiy@Taro.com

+1 914-345-9001

Study Officials

• Novum Pharmaceutical Research Services

  http://www.novumprs.com/contact

  STUDY CHAIR

• Natalie Yantovskiy

  Taro Pharmaceuticals USA Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2016
• First Posted: October 13, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: September 29, 2017
• Last Updated: December 6, 2018
• Results First Posted: December 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share