NCT06855745 Phase 2 Randomized Double-blind Study to Assess Topical Zabalafin Hydrogel Vs Vehicle in Mild to Moderate AD.
| NCT ID | NCT06855745 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Alphyn Biologics |
| Condition | Atopic Dermatitis (Eczema) |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-03-25 |
| Primary Completion | 2025-10-30 |
Trial Parameters
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Brief Summary
A Phase 2b study investigating the efficacy of zabalafin in people with mild to moderate atopic dermatitis (eczema).
Eligibility Criteria
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 who have at least 1 lesion that measures approximately 5 cm2 or more at Screening and Day 1. Lesion must be representative of the participant's atopic dermatitis and not be located on the hands, feet,
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