Psoriasis Clinical Trial
Official title:
Olux E Foam and Sorilux Foam Combination Therapy for the Maintenance of Treatment Response in Patients With Moderate Plaque Psoriasis
The purpose of the study is to investigate if combined use of OLUX-E™ Foam and SORILUX Foam
may help "maintain" the therapeutic benefit that is achieved with OLUX-E™ Foam in the
treatment of moderate plaque psoriasis.
OLUX-E™ is a medication that contains a corticosteroid delivered in a foam formulation.
SORILUX Foam is a foam formulation of calcipotriene. Both medications have been approved by
the FDA for treating plaque psoriasis.
This is a single-center, investigator-blind study. Approximately 60 qualified subjects will
be enrolled into a 2 week treatment phase where they will receive 2 weeks of treatment with
Olux E foam. After 2 weeks treatment, subjects with a PGA of 0 or 1 will be re-randomized
into maintenance phase.
Subjects that achieve PGA scores of >2 will be discontinued from the study and will not be
randomized. Subjects that achieve PGA scores of 0 or 1 will enter an 8 week maintenance
phase where they will be randomized on a 1:1:1 basis to one of the following treatment
groups:
- Vehicle foam (BID)
- Sorilux foam (BID)
- Sorilux foam (BID on weekdays) + Olux E foam (BID on weekends)
Subjects will then attend clinic visits at week 6. At week 10 study treatment will be
stopped.
The maximum duration of the study is 10 weeks and consists of a Screening/Baseline Visit
(Week -0), Re-randomization to maintenance phase visit (Week 2), treatment follow-up visits
at Weeks 6, and end of treatment visit at weeks 10.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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