Ammonium Lactate Lotion 12% (Lac-hydrin®) and Halobetasol Propionate Ointment 0.05% (Ultravate®) in the Treatment and Maintenance of Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%); Lac-Hydrin lotion (ammonium lactate lotion 12%); placebo ointment
Intervention description: Steroid on weekends only group; Placebo on weekends only group
Intervention MeSH terms: Halobetasol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: plaque psoriasis; lac-hydrin; ammonium lactate; Ultravate; halobetasol propionate; weekend only application; topical therapy; topical corticosteroid; class I steroid

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.
    

Eligibility 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.