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.
* 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
20
Subjects will be evaluated at baseline, Day 3 and Day 6 (or end of study).
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Subjective Subject Preference Survey for the First Treatment Session
Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.
Time frame: 3 days
Subjective Subject Preference Survey for the Second Treatment Session
Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.
Time frame: 3 days
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