Plaque Psoriasis Clinical Trial
Official title:
Patient Preference of Taclonex Ointment to Taclonex Scalp Suspension in Adult Subjects With Psoriasis Vulgaris
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.
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