CompletedPhase 4

Comparing the Efficacy of Ultravate Ointment in Combination With Lac-Hydrin Lotion in the Treatment of Psoriasis

United States40 participantsStarted 2009-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinically diagnosed by an investigator to have stable plaque psoriasis with no more than 10% body surface area involvement. * A subject must have an overall baseline score of 6 (moderate) or greater based on a twelve-point scale on the Psoriasis Severity Assessment (PSA) form. Elevation, erythema, and scale will each be graded on a four point scale with a maximum total of 12 points. Each of these 3 variables should be scored as at least a two. (Plaque elevation is defined as the total elevation, including adherent scales, relative to the surrounding skin). * For female patients of childbearing potential, a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation). * Negative urine pregnancy test at the time of study entry (for female patients of childbearing potential). * Written, informed consent and photographic release. * Ability to follow study instructions and likely to complete all required visits. Exclusion Criteria: * A female subject who is pregnant, nursing an infant or planning a pregnancy during the study (throughout the course of the study, women of childbearing potential must use reliable forms of contraception \[i.e., abstinence, spermicides, condoms, or other reliable forms of contraception other than oral contraceptives\]. * A subject with any uncontrolled systemic disease. A potential subjec…

What they're measuring

Change in Modified Psoriasis Area Severity Index (PASI) Score

Timeframe: 2 weeks

Trial details

NCT IDNCT00990561

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-06

Results submitted2012-01-19