8-Week Atopic Dermatitis (AD) Treatment Study
Condition: Atopic Dermatitis Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Investigational OTC Cream; 0.05% Desonide; Placebo Cream
Intervention description: Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.; Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.; Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
Intervention MeSH terms: Desonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized and balanced into one of the 3 treatment groups by their baseline SCORAD grade (moderate = 25-40 and severe = 41+) and ethnicity (black or non-black).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: As above
Enrollment: 65.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a study to investigate the clinical effectiveness of the Sponsor's experimental cream
      treatment on eczema as measured by visual grading of SCORAD (scoring of atopic dermatitis).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is a generally healthy, male or female, 12-65 years old, inclusive;

          -  Diagnosis of moderate or greater Atopic Dermatitis as determined by SCORAD (SCORAD
             >=25);

          -  Is able to read and understand instructions in English.

        Exclusion Criteria:

          -  Is currently participating or has participated in another interventional clinical
             study in the past 2 weeks;

          -  Currently or has been diagnosed or treated for cancer in the past 5 years;

          -  Requires any topical or systemic medications that could affect the course of their
             atopic dermatitis during the study period (except inhaled steroids and/or stable
             antihistamines for asthma or allergies);

          -  Has used systemic treatments that could affect AD within 30 days or 5 half- lives.
             (i.e. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea),
             azathioprine and oral/injectable corticosteroids);

          -  Has a known hypersensitivity to any corticosteroid creams;

          -  Has been diagnosed with any allergies to Oat or derivatives;

          -  Has any active infections or has used antibiotics in the past 7 days;

          -  Has any physical attributes or skin conditions that might interfere with the clear
             visual or instrumental assessments.(i.e. cuts, sunburn, birth marks, tattoos,
             extensive scarring, excessive hair growth or acne);

          -  Has an immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS,
             lupus rheumatoid arthritis) which could place the subject at risk or interfere with
             the accuracy of the study results;

          -  Has used any immunosuppressant drugs or immunotherapy within the past 30days or 5
             half-lives;

          -  Is an employee of the sponsor company or clinical testing site;

          -  Is diabetic;

          -  Presents with the presence of an active or chronic allergic reaction as evidenced by
             an irregular white cell count determined by eosinophils > 0.3 X 109/L at Screening
             Visit;

          -  Is planning a trip to a sunny climate, to use tanning booths or use other UV sources
             throughout the course of this study;

          -  Has a history of hypersensitivity to any substance in investigational preparation or
             to Desonide;

          -  Has any clinically significant medical condition or laboratory abnormality that would,
             in the opinion of the Investigator, put the patient at undue risk or interfere with
             the interpretation of the study results;

          -  Is dependent on oral medication for any skin disease/condition or could not, in the
             opinion of the Investigator tolerate the restriction of discontinuing the medicine as
             required in this study;

          -  Is currently pregnant or lactating or planning to become pregnant in the next 6
             months;

          -  Has other skin conditions that might interfere with AD diagnosis and/or evaluation
             (i.e. psoriasis current active viral, bacterial and fungal skin infections) as
             assessed by the Investigator;

          -  Any other condition or factor the Investigator or their duly assigned representative
             believes may affect the ability of the subject to complete the study or the
             interpretation