Study to Evaluate Efficacy and Safety of the Topical Product in Patients With Mild to Severe Scalp Psoriasis
Primary Purpose
Scalp Psoriasis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DSXS
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Scalp Psoriasis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DSXS 1535
Placebo
Arm Description
DSXS 1535 topical product
Vehicle
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02932462
First Posted
October 8, 2016
Last Updated
November 12, 2018
Sponsor
Taro Pharmaceuticals USA
1. Study Identification
Unique Protocol Identification Number
NCT02932462
Brief Title
Study to Evaluate Efficacy and Safety of the Topical Product in Patients With Mild to Severe Scalp Psoriasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
September 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III Clinical Study
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scalp Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
373 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DSXS 1535
Arm Type
Experimental
Arm Description
DSXS 1535 topical product
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
DSXS
Other Intervention Name(s)
DSXS 1535
Intervention Description
topical product
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
vehicle
Intervention Description
topical product
Primary Outcome Measure Information:
Title
Clinical Success in Patients With Moderate and Severe Scalp Psoriasis
Description
IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
Time Frame
from baseline to study day 29
Title
Clinical Success in Patients With Mild to Severe Scalp Psoriasis
Description
IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
Time Frame
from baseline to study day 29
Secondary Outcome Measure Information:
Title
Clinical Success in Patients With Mild Scalp Psoriasis
Description
IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
Time Frame
from baseline to study day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novum Pharmaceutical Research Services
Organizational Affiliation
http://www.novumprs.com/contact
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Natalie Yantovskiy
Organizational Affiliation
Taro Pharmaceuticals USA Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate Efficacy and Safety of the Topical Product in Patients With Mild to Severe Scalp Psoriasis
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