Safety and Efficacy of CD5024 0.3% Cream in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: CD5024 0.3% cream; Placebo
Intervention description: Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 milligrams per centimeter square (mg/cm^2) once daily for 6 weeks.; Participants applied placebo matched to CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.
Intervention MeSH terms: Ivermectin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      Exploratory, multi-centric, randomized, vehicle-controlled, investigator-blind, parallel
      group study, involved participants with chronic lesions of Atopic Dermatitis (AD) to evaluate
      the local and systemic safety of CD5024 0.3% cream over a 6-week treatment period compared to
      its vehicle.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant was a male or female aged 18 to 60 years old inclusive at Screening.

          2. The participant presented with a total body surface area (tBSA) less than or equal to
             (>=) 2 square meter (m^2) at Screening.

          3. The participant had atopic dermatitis for at least 6 months prior to Day 1. The
             clinical diagnosis of atopic dermatitis must be confirmed with the criteria of Hanifin
             and Rajka at the screening visit.

          4. Atopic dermatitis must be stable for at least one month before the screening visit
             (according to participant).

          5. The participant had a Body Surface Area (BSA) affected by AD ranging from 1% inclusive
             to 10% inclusive at Day 1, excluding scalp and genitals.

          6. The participant had an overall Investigator's Global Assessment (IGA) score of 3
             (moderate) at Day 1;

        Exclusion Criteria:

          1. The participant was a pregnant female, is breastfeeding or intends to conceive a child
             during the study,

          2. The participant had any uncontrolled or serious disease, or any medical or surgical
             condition, that may either interfere with the interpretation of the clinical trial
             results (e.g. extensive scaring or pigmented lesion in a treated area), and/or put the
             participant at significant risk according to Investigator's judgment if he/she
             participates in the clinical trial (e.g. active cancer, AIDS, insulin-dependent
             diabetes…) at Screening or Day 1.

          3. The participant presented with an acute flare of AD at Day 1.

          4. The participant had active cutaneous bacterial or viral infection in any treated area
             at baseline (e.g. clinically infected AD) at Screening or Day 1.

          5. The participant had a history of confounding skin condition (e.g. psoriasis,
             erythroderma) or a history of Netherton syndrome at Screening.

          6. The participant had a past history of serious persistent neurological disorders such
             as seizures, multiple sclerosis, or neurological signs or symptoms at Screening.