Ammonium Lactate Lotion 12% (Lac-hydrin®) and Halobetasol Propionate Ointment 0.05% (Ultravate®) in the Treatment and Maintenance of Psoriasis
NCT01111123 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2016-06-24
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.
Conditions
Interventions
- DRUG
-
Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%)
Steroid on weekends only group
- DRUG
-
Lac-Hydrin lotion (ammonium lactate lotion 12%); placebo ointment
Placebo on weekends only group
Sponsors & Collaborators
-
Icahn School of Medicine at Mount Sinai
lead OTHER
Principal Investigators
-
Jason J Emer, MD · Icahn School of Medicine at Mount Sinai
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-01-31
- Primary Completion
- 2010-03-31
- Completion
- 2010-03-31
Countries
- United States
Study Locations
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