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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932462


Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Chair: Novum Pharmaceutical Research Services http://www.novumprs.com/contact
Study Director: Natalie Yantovskiy Taro Pharmaceuticals USA Inc.
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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02932462    
Other Study ID Numbers: DSXS 1535
First Posted: October 13, 2016    Key Record Dates
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases