Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: AN2728 Topical Ointment, 2% QD; AN2728 Topical Ointment, 0.5% QD; AN2728 Topical Ointment, 2% BID; AN2728 Topical Ointment, 0.5% BID
Intervention description: AN2728 Topical Ointment, 2% QD; AN2728 Topical Ointment, 0.5% QD; AN2728 Topical Ointment, 2% BID; AN2728 Topical Ointment, 0.5% BID
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 86.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: atopic dermatitis

Summary:

      The purpose of this study is to determine the safety and efficacy of AN2728 Topical Ointment,
      2% and 0.5%, administered once a day (QD) or twice a day (BID), in the treatment of
      adolescents with atopic dermatitis (AD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 12 to 17 years of age, inclusive

          -  Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and
             Rajka)

          -  Total body surface area (BSA) of atopic dermatitis involvement ≤35%

          -  Presence of two comparable target lesions

          -  Willing and able to comply with study instructions and commit to attending all visits

          -  Females of childbearing potential must use a highly effective method of birth control.
             Males with partners of childbearing potential should inform them of their
             participation in this clinical study and use a highly effective method of birth
             control during the study.

          -  Parent/guardian has the ability to understand, agree to and sign the study Informed
             Consent Form (ICF) prior to initiation of any protocol-related procedures; subject has
             the ability to give assent

        Exclusion Criteria:

          -  Significant confounding conditions as assessed by study doctor

          -  Unstable or actively infected AD

          -  Active or potentially recurrent dermatologic condition other than atopic dermatitis in
             the target lesion area that may confound evaluation

          -  History or evidence of allergies requiring acute or chronic treatment (except seasonal
             allergic rhinitis)

          -  Concurrent or recent use of certain topical or systemic medications or phototherapy
             without a sufficient washout period

          -  Treatment for any type of cancer (except squamous cell carcinoma, basal cell
             carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or
             surgical excision only) within the last 5 years

          -  Current pregnancy or lactation, or intent to become pregnant during the study

          -  Known sensitivity to any of the components of the study drug

          -  Participated in any other trial of an investigational drug or device within 30 days or
             participation in a research study concurrent with this study

          -  Participated in a previous AN2728 clinical study