Ammonium Lactate Lotion 12% (Lac-hydrin®) and Halobetasol Propionate Ointment 0.05% (Ultravate®) in the Treatment and Maintenance of Psoriasis

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Treatments: Clobetasol; Halobetasol

Criteria

Inclusion Criteria:

• Subjects must be at least 18 years of age and in good general health as confirmed by a medical history.

• Females of childbearing potential must have a negative urine pregnancy test on Day 1 and must agree to use adequate birth control methods during the entire study.

• A clear diagnosis of plaque psoriasis must have been previously established and the disease must have been present at least 6 months.

• Subjects must have lesions suitable for evaluating response to test agents. The severity of the disease at Day 1 must be rated at least 2 (Mild) for each of the key psoriasis characteristics (scaling, erythema, and plaque elevation).

• Subjects must be able to understand the requirements of the study, abide by the restrictions, and return for the required examinations. All subject must sign the statement of informed consent approved for the study.

Exclusion Criteria:

• Subjects who are pregnant (determined from a urine pregnancy test on Day 1).

• Subjects who are nursing.

• Subjects with known hypersensitivity to any components of the test medication.

• Subjects requiring any other medication (topical or systemic) that may affect the course of the disease during the study period (e.g. antibiotics, sedating antihistamines).

• Subjects using biologics or any other systemic treatment for psoriasis within 12 weeks of entering the study.

• Subjects using systemic corticosteroids within 28 days of entering the study; subjects using topical corticosteroids or other topical therapies (other than emollients) at any location on the body within 1 week of entering the study.

• Subjects with overt pre-existing telangiectasia or skin atrophy at intended treatment sites.

• Subjects who are using any medication or has any disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study.