A Randomized, Double-blind Study to Evaluate the Efficacy of Ammonium Lactate Lotion 12% (Lac-hydrin®) and Halobetasol Propionate Ointment 0.05% (Ultravate®) in the Treatment and Maintenance of Psoriasis.

NCT01111123 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	Phase 4
Status	COMPLETED
Enrolment	55
Start date	2009-01
Completion	2010-03

Conditions

• Plaque Psoriasis

Interventions

• Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%)
• Lac-Hydrin lotion (ammonium lactate lotion 12%); placebo ointment

Primary outcomes

• Physical Global Assessment — During the maintenance phase, from 2 weeks up to 26 weeks
  Physician global assessment (PGA) score - the physician's impression of the disease at a single time point rated as: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe.

Countries

United States