Phase 2 Randomized Double-blind Study to Assess Topical Zabalafin Hydrogel Vs Vehicle in M
A Phase 2b study investigating the efficacy of zabalafin in people with mild to moderate atopic dermatitis (eczema).
| Condition(s) | Atopic Dermatitis (Eczema), Atopic Dermatitis Eczema, Atopic Dermatitis, Atopic Dermatitis (AD), Eczema, Eczema, Atopic |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | A Phase 2b study investigating the efficacy of zabalafin in people with mild to moderate atopic dermatitis (eczema). |
| Who can participate | Inclusion Criteria: 1. Male/female participants who are ≥2 years of age on the day of providing documented informed consent/assent. 2. Have a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka (1980) at the Screening visit and a history of AD for at least 6 months (3 months for children under the age of 6). 3. Mild to moderate AD indicated by vIGA (Validated Investigator's Global Assessment) score of 2 (mild) or 3 (moderate) at Screening and at Day 1 prior to application of study intervention. 4. Have AD on the head (including face, but excluding hair-bearing scalp), neck, trunk (excluding groin and genitals), or limbs, covering at least ≥2% of total BSA (body surface area) and not more than 20% at Screening and at Day 1 (Visit 1). 5. Participants w |
| Ages | 2 Years |
| Sex | All |
| Lead sponsor | Alphyn Biologics |
| Locations | Brookvale, New South Wales, Australia; Darlinghurst, New South Wales, Australia; Kogarah, New South Wales, Australia; Kogarah, New South Wales, Australia; Kotara, New South Wales, Australia; Waitara, New South Wales, Australia (+6 more sites) |
| Start date | 2025-03-25 |
| NCT ID | NCT06855745 |
| Official listing | https://clinicaltrials.gov/study/NCT06855745 |