SHP-141C in Plaque Type Psoriasis
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|ClinicalTrials.gov Identifier: NCT01646567|
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : July 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Plaque Type Psoriasis||Drug: SHP-141C Drug: Placebo to SHP-141C Drug: Betamethasone Valerate Drug: Calcipotriol||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind, Within-Subject Randomised, Placebo-Controlled, Proof of Concept, Comparison Study of SHP-141C Topical Cream in Psoriasis, Using the Microplaque Assay.|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Experimental: SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate
A 100 mg dose of SHP-141C cream at three concentrations (0.5%, 1.0% and 2.0%), a matched placebo cream and two reference treatments: Calcipotriol 0.005% cream and Betamethasone Valerate 0.02% cream, applied topically to a selected plaque on each subject, six times per week over 28 days for a total of 24 doses.
Other Name: SHAPEDrug: Placebo to SHP-141C
Placebo Topical Cream
Other Name: Placebo to SHAPEDrug: Betamethasone Valerate
Topical cream, 0.02%
Other Name: Celestone-MDrug: Calcipotriol
Topical cream, 0.005%
Other Name: Daivonex
- Change from baseline in Local Plaque Severity Index (LPSI) [ Time Frame: Baseline, day 15, day 33 ]Measurement of plaque severity including erythema, induration, and desquamation.
- The number of patients with adverse events [ Time Frame: daily to and including Day33 ]Adverse event data for each subject will be collected.
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): NCT01646567
|Nucleus Network Limited|
|Melbourne, Victoria, Australia, 3004|
|Principal Investigator:||Peter Foley||The Alfred|