Conditions: Plaque Psoriasis
Keywords: plaque psoriasis taclonex crossover
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 20
Healthy volunteers: yes

Brief summary:
This is an open label, investigator-blinded, cross over, prospective, single center study of subjects with plaque psoriasis. Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment and Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension will each be applied topically once daily.

The primary objective is to assess the patient preference for Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment compared to Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension in the treatment of plaque psoriasis.

Detailed description:
* Following satisfaction of entry criteria, all subjects at the Baseline/Screening visit will be randomized 1:1 to receive either Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment or Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension to use once daily for three days to affected areas of the body, excluding face and intertriginous areas. Subjects will be aware of which product they are using. Investigators will remain blinded.
* Subjects will be randomized to use either the ointment or the scalp suspension for the first three day treatment period, then cross over to use the other product for second three day treatment period.
* Each medication will be used within its FDA-approved label for the treatment of plaque psoriasis in subjects aged 18 and older. Subjects may not treat areas of the face, axilla or groin in this study.
* At the Day 3 and Day 6 visits the subjects will complete a questionnaire about their psoriasis treatment preferences.
* Pregnancy tests will be done on females of childbearing potential at Baseline/Screening.
* Adverse events will be monitored at each visit.

Arms:
arm 1: All subjects will use Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily for three days to affected areas, then switch to Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas for three days arm 2: All subjects will use Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension once daily to affected areas for three days, then switch to Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment once daily for three days to affected areas,

Interventions: intervention 1: Taclonex
Intervention descriptions: intervention 1: Subjects will be evaluated at baseline, Day 3 and Day 6 (or end of study).

Protocol document: