Comparing the Efficacy of Ultravate Ointment in Combination With Lac-Hydrin Lotion in the Treatment of Psoriasis
Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
Participant gender:
Summary
This is an investigator-masked, randomized, parallel, clinical study comparing the efficacy
of once daily versus twice daily application of Ultravate® ointment (halobetasol propionate
0.05% ointment) in combination with Lac-Hydrin lotion (ammonium lactate topical) in the
treatment of stable plaque psoriasis. 1) Phase 1: Patients will be treated for two weeks with
combination therapy using Ultravate® ointment with Lac-Hydrin lotion and their psoriasis
plaques will be evaluated to test efficacy of the medication. Half the subjects will be
randomized to receive treatment with once a day Ultravate® ointment and twice daily
Lac-Hydrin lotion; the other half of subjects will receive twice daily Ultravate® ointment
with twice daily Lac-Hydrin lotion. Ultravate® ointment will be discontinued following two
weeks of treatment, in compliance with its FDA indication. Phase 2: The second treatment
phase will consist of a four-week observation period. Subjects will be re-randomized to
either continue using twice daily Lac-Hydrin lotion, versus no treatment. The purpose of this
second phase of the study is to investigate whether use of Lac-Hydrin monotherapy twice daily
can minimize risk of recurrence and maximize duration of therapeutic effect. Part of this
clinical study consists of the use of patient and physician satisfaction questionnaires.
These questionnaires will include questions about the satisfaction with the formulation of
each agent, questions about compliance with treatment, etc. Such questions could be used to
demonstrate patient and physician satisfaction with each agent, with combination therapy, and
to compare patient satisfaction rates among those randomized to once daily versus twice daily
application of Ultravate® ointment. The hypothesis is that Ultravate ointment once daily in
combination with Lac-Hydrin twice daily is equal in efficacy to Ultravate ointment twice
daily in combination with Lac-Hydrin twice daily.