Phase 2
N=151
A Randomized Double Blind Vehicle Controlled Dose Ranging Parallel Design Multiple Site Clinical Study
Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02413229 ↗Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Clinical Response of Success — 6; 4; 6; 1 Participants — p=0.3571
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DSXS1411 (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Sun Pharmaceutical Industries, Inc.
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response of Success |
6; 4; 6; 1; 6; 1 | 0.3571 |
Summary
The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and a Placebo in patients with moderate to severe scalp psoriasis.
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant, non-lactating females age 12 and older.
- Clinical diagnosis of moderate to severe scalp psoriasis, defined by a Investigator's Global Assessment score of at least 3 at screening.
Exclusion Criteria
- Under 12 years of age.
- Patients whose scalp and/or non-scalp psoriasis necessitates systemic or other concomitant topical therapies during the study.
- Has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp.
Data sourced from ClinicalTrials.gov (NCT02413229). 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.