A Study for a Topical Medication Versus Placebo in Patients With Hand Dermatitis
Condition: Hand Dermatitis
MeSH terms: Dermatitis
Intervention: Topical AFX5931; Topical Placebo
Intervention description: Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule.; Placebo Comparator, Topical Placebo.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a double-blind, pilot study with 20 subjects to determine the tolerability and
      efficacy of topical AFX 5931 in the treatment of mild to moderate hand dermatitis. Subjects
      are screened up to 30 days before the baseline visit. Subjects who meet the eligibility
      criteria may qualify for the study. Subjects will be randomized in a 3:1 ratio to receive
      either the active or vehicle medication. 15 subjects will receive the active, therapeutic
      product and 5 subjects will receive the inactive, vehicle product.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is a male or non-pregnant female, 12 years of age and older.

          2. Subject is willing and able to provide written informed consent for the study.

          3. Subject is willing and able to apply the investigational product as directed, comply
             with study instructions and commit to all follow-up visits for the duration of the
             study.

          4. Subject has clinical diagnosis of mild to moderate hand dermatitis for at least 3
             months.

          5. Subject has a baseline Investigator's Global Assessment (IGA) score of 2 or 3 (disease
             severity of mild or moderate).

          6. Subject is in good general health and free of any disease state or physical condition
             that might impair evaluation of hand dermatitis or which, in the investigator's
             opinion, exposes the subject to an unacceptable risk by study participation.

          7. Women of childbearing potential (WOCBP) must use an effective method of birth control
             or must be post-menopausal or surgically sterile. Women of childbearing potential
             (WOCBP) must have a negative urine pregnancy test (UPT) at Baseline.

        Exclusion Criteria:

          1. Subject is pregnant, lactating, or is planning to become pregnant during the study.

          2. Subject is currently enrolled in an investigational drug or device study.

          3. Subject has used an investigational drug or investigational device treatment within 30
             days prior to Visit 2/Baseline.

          4. Subject has active cutaneous bacterial or viral infection in any treatment area
             (clinically infected hand dermatitis) at Visit 2/Baseline.

          5. Subject has used any of the following therapies within 30 days prior to Visit
             2/Baseline:

               -  Systemic corticosteroids (oral and injectable [intravenous and intramuscular])
                  (Intranasal and Inhalational steroids are allowed if use is kept constant during
                  the study)

               -  UVA/UVB therapy

               -  PUVA (psoralen plus ultraviolet A) therapy

               -  Immunomodulators or immunosuppressive therapies

               -  Interferon

               -  Cytotoxic drugs (e.g., methotrexate, cyclophosphamide, azathioprine)

               -  Oral retinoids

          6. Subject has used any of the following therapies within 14 days prior to Visit
             2/Baseline:

               -  Systemic antibiotics

               -  Topical calcipotriene or other topical vitamin D preparations

          7. Subject has used any of the following therapies within 7 days prior to Visit
             2/Baseline: • Topical and oral antihistamines

               -  Topical antibiotics

               -  Topical corticosteroids

               -  Topical antifungals

          8. Subject has a history of sensitivity to any of the ingredients in the investigational
             product

          9. Subject is known to be noncompliant or is unlikely to comply with the requirements of
             the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in
             the opinion of the investigator.