Safety and Efficacy Study of Topically Applied DS107 Cream in Mild to Moderate Atopic Dermatitis Patients (AD)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: DS107; Vehicle cream
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 327.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this randomized, double blind, placebo controlled, parallel group study is to
      compare the safety and efficacy of topically applied DS107 cream (1% and 5%) versus vehicle
      cream, in the treatment of adult patients with mild to moderate Atopic Dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a clinically confirmed diagnosis of active Atopic Dermatitis according
             to Hanifin and Rajka criteria

          -  Patients with mild to moderate Atopic Dermatitis at baseline as defined by an
             Investigator's Global Assessment (IGA) score of 3 or 2 at baseline visit

          -  Patients with Atopic Dermatitis covering a minimum 5% of the body surface area at
             baseline

          -  Male or female patients aged 18 years and older on the day of signing the informed
             consent form (ICF)

        Exclusion Criteria:

          -  Patients with other skin conditions that might interfere with Atopic Dermatitis
             diagnosis and/or evaluation (such as psoriasis or current active viral, bacterial and
             fungal topical skin infections) as assessed by the Investigator

          -  Patients who have used systemic treatments (other than biologics) that could affect
             Atopic Dermatitis less that 4 weeks prior to baseline visit (Day 0), e.g. retinoids,
             methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and
             oral/injectable corticosteroids. Intranasal corticosteroids for stable medical
             conditions are allowed

          -  Patients who have used any topical medicated treatment for Atopic Dermatitis two weeks
             prior to the start of treatment/baseline (Day 0) including but not limited to, topical
             corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials, and bleach
             baths

          -  Patients who use topical products containing urea, ceramides or hyaluronic acid two
             weeks prior to Day 0

          -  Patients who have a history of hypersensitivity to any substance in DS107 cream or
             vehicle cream

          -  Patients who have any clinically significant controlled or uncontrolled 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 study results

          -  Patients with significant uncontrolled cardiovascular, neurologic, malignant,
             psychiatric, respiratory or hypertensive disease, as well as uncontrolled diabetes and
             floride arthritis or any other illness that, in the opinion of the Investigator, is
             likely to interfere with completion of the study

          -  Patients with chronic infectious diseases (e.g. hepatitis B, hepatitis C, or infection
             with human immunodeficiency virus)