Clinical trial NCT01111123
Conditions: Plaque Psoriasis
Keywords: plaque psoriasis lac-hydrin ammonium lactate Ultravate halobetasol propionate weekend only application topical therapy topical corticosteroid class I steroid
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2009-01-01; Completion date: 2010-03-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the combinational use of ammonium lactate lotion 12% (Lac-Hydrin) and halobetasol propionate ointment 0.05% (Ultravate) is safe and effective in the initial treatment and long-term maintenance of psoriasis. Patients will use both medications continuously for two weeks and those who obtain a good improvement based on investigator clinical assessments will be randomized to Lac-Hydrin lotion twice daily every day with placebo ointment or Ultravate ointment twice daily on weekends only for up to 24 more weeks.

Detailed description:
This is a randomized, double-blind, placebo-controlled, clinical trial assessing the efficacy of Ultravate ointment in combination with Lac-Hydrin lotion in the treatment of plaque psoriasis. In the first phase, patients will be treated for two weeks with combination therapy using Ultravate ointment twice daily along with Lac-Hydrin lotion twice daily. After two weeks, psoriasis plaques will be evaluated to test treatment efficacy. Those patients with a significant clinical improvement per investigator clinical assessments, will be randomized in a 1:1 fashion into a maintenance phase and receive Lac-Hydrin lotion twice daily everyday with placebo ointment or Ultravate ointment twice daily on weekends only. Continuous use of Ultravate ointment will be discontinued following two weeks of treatment in compliance with its FDA indication. Patients will be evaluated every 4 weeks (monthly) through the maintenance phase. The purpose of this second phase of the study is to investigate whether use of Ultravate on weekends only can minimize risk of plaque recurrence, maximize duration of therapeutic effect, while limiting the need for the use of long-term continuous topical corticosteroid treatment. As well, the second phase of the study is to investigate whether twice daily Lac-Hydrin lotion has an impact in maximizing the duration of therapeutic effect as well as minimizing local cutaneous side effects such as skin atrophy and telangiectasia. Part of this clinical study consists of the use of patient and self-assessment questionnaires and the use of non-identifying digital photography of target lesions. The hypothesis is that Ultravate ointment on weekends only will be statistically more efficacious at maintaining an excellent initial clinical response and its combination with Lac-Hydrin lotion will help to minimize any local cutaneous side effects as well as enhance its therapeutic effect.

Arms: arm 1: Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only arm 2: Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only
Interventions: intervention 1: Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%) intervention 2: Lac-Hydrin lotion (ammonium lactate lotion 12%); placebo ointment
Intervention descriptions: intervention 1: Steroid on weekends only group intervention 2: Placebo on weekends only group

Protocol documents: