Clinical trial NCT02932462: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scalp Psoriasis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2016-10-13
Enrollment: 373
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Clinical Success in Patients With Moderate and Severe Scalp Psoriasis
timeFrame: from baseline to study day 29
measure: Clinical Success in Patients With Mild to Severe Scalp Psoriasis
timeFrame: from baseline to study day 29
Secondary outcomes:
measure: Clinical Success in Patients With Mild Scalp Psoriasis
timeFrame: from baseline to study day 29
Other outcomes:
Locations:
Study officials:
affiliation: http://www.novumprs.com/contact
name: Novum Pharmaceutical Research Services
role: STUDY_CHAIR
affiliation: Taro Pharmaceuticals USA Inc.
name: Natalie Yantovskiy
role: STUDY_DIRECTOR
References: