Phase 3
N=373
Study to Evaluate Efficacy and Safety of the Topical Product in Patients With Mild to Severe Scalp Psoriasis
Scalp Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02932462 ↗Enrolled (actual)
373
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Clinical Success in Patients With Moderate and Severe Scalp Psoriasis — 41; 43 Participants — p=0.4557
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DSXS (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Sun Pharmaceutical Industries, Inc.
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Success in Patients With Moderate and Severe Scalp Psoriasis |
41; 43 | 0.4557 |
| PRIMARY Clinical Success in Patients With Mild to Severe Scalp Psoriasis |
51; 50 | 0.8096 |
| SECONDARY Clinical Success in Patients With Mild Scalp Psoriasis |
10; 7 | 0.7652 |
Summary
A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III Clinical Study
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.
Data sourced from ClinicalTrials.gov (NCT02932462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.