Conditions: Psoriasis
Keywords: Olux E foam Sorilux foam
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 63
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks arm 2: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x arm 3: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks

Interventions: intervention 1: vehicle foam intervention 2: calcipotriene intervention 3: calcipotriene + clobetasol propionate
Intervention descriptions: intervention 1: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks intervention 2: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks intervention 3: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks

Protocol document: