Study to Evaluate Product Duration of Use Experience With Alclometasone Dipropionate Cream
Condition: Eczema; Allergy Symptoms; Psoriasis; Itch
MeSH terms: Psoriasis; Eczema
Intervention: Alclometasone dipropionate cream
Intervention description: Alclometasone dipropionate cream 0.05% (15 g)
Intervention MeSH terms: Alclometasone dipropionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 310.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alclometasone dipropionate; Eczema; Psoriasis; Itch

Summary:

      This is a multi-center, open-label study to evaluate whether participants follow the duration
      of use instructions for short-term use of alclometasone dipropionate in a population of
      participants with itchy skin conditions who would use OTC treatments for relief. The study
      population will be composed of two different cohorts: chronic condition sufferers (eczema or
      psoriasis) and participants who suffer from occasional itchy skin experiences (such as poison
      ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or
      soaps) where an anti-itch medication would be used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: At least 12 years of age.

          -  Condition: Currently experiencing itch associated with one of the following skin
             conditions:

               -  psoriasis or eczema,

               -  minor skin conditions such as those caused by poison ivy, oak, or sumac, insect
                  bites, or use of cosmetics, soaps, detergents, or jewelry.

          -  Compliance: Subject or subject's parent or legal guardian understands and is willing,
             able and likely to comply with all study procedures and restrictions.

          -  Consent: Subject or subject's parent or legal guardian demonstrates ability to read
             and understand English and is willing to participate as evidenced by voluntary written
             informed consent and has received a signed and dated copy of the informed consent form
             (and assent as appropriate).

        Exclusion Criteria:

          -  Pregnancy: Women who are known to be pregnant (as self-reported) or who are intending
             to become pregnant over the duration of the study. Women of childbearing potential
             will be allowed to participate in the study so long as they are practicing a reliable
             method of contraception (e.g. hormonal birth control such as pill, patch, implant or
             injection; intrauterine device, double barrier methods, tubal ligation, vasectomized
             spouse or abstinence).

          -  Corticosteroid Use: Subject has used a corticosteroid treatment within two weeks of
             the screening visit at the start of the study.

          -  Breast-feeding: Women who are breastfeeding.

          -  Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to
             alclometasone cream (or closely related compounds), or any of their stated
             ingredients.

          -  Participation in another clinical study or receipt of an investigational drug within
             30 days of the screening visit at the start of the study.