Actively Recruiting
A Phase 2, Randomized, Double-blind Study to Assess Topical Zabalafin Hydrogel Versus Placebo in Mild to Moderate Atopic Dermatitis
Led by Alphyn Biologics · Updated on 2025-08-01
72
Participants Needed
12
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of zabalafin hydrogel in people aged 2 years and older who have mild to moderate atopic dermatitis, also known as eczema. This Phase 2b randomized, double-blind study includes two groups: one with mild to moderate atopic dermatitis and another with the same condition plus a secondary skin infection. The study aims to compare zabalafin hydrogel to a placebo (vehicle) to understand its impact on eczema symptoms using a validated global assessment scale. Participants will be randomly assigned in a 2:1 ratio to receive either zabalafin 9.5% hydrogel or a placebo gel. The study treatment lasts 16 weeks following up to 2 weeks of screening. During treatment, participants will visit the clinic every 2 weeks for the first month and then monthly until the end of the study. The study evaluates not only the effectiveness but also the safety and tolerability of zabalafin compared to the placebo. Throughout the study, participants will undergo assessments including the validated Investigator's Global Assessment, Eczema Area and Severity Index, pruritus (itching) rating, and patient-reported eczema measures. Safety monitoring and evaluation of antibacterial effects in those with skin infections are included. Participants must comply with study procedures, avoid using other topical products on the eczema lesions, and attend scheduled visits over the approximately 16-week treatment period.
CONDITIONS
Brief Title
Phase 2 Randomized Double-blind Study to Assess Topical Zabalafin Hydrogel Vs Vehicle in Mild to Moderate AD.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 2 years or older on the day of consent
- Clinical diagnosis of atopic dermatitis with a history of at least 6 months (3 months for children under 6 years)
- Mild to moderate atopic dermatitis with a validated Investigator's Global Assessment (vIGA) score of 2 or 3 at screening and Day 1
- Atopic dermatitis on the head, neck, trunk, or limbs covering between 2% and 20% of total body surface area
- At least one eczema lesion measuring approximately 5 cm2 or more, not on hands, feet, or genitalia
- Eczema Area and Severity Index (EASI) total score between 3 and 21 at screening and Day 1
- Peak pruritus Numeric Rating Scale (NRS) score of at least 4 at screening and Day 1
- Stable use of allowed oral and topical medications for at least 14 days prior to Day 1
- Willingness to avoid using other topical products on eczema lesions during treatment
- Ability and willingness to comply with all study procedures and visits
- Women must not be pregnant or breastfeeding and must follow contraceptive guidance if of childbearing potential; men must also follow contraceptive guidance
You will not qualify if you...
- Unstable atopic dermatitis in the 4 weeks before Day 1
- Other skin disorders or extensive scarring that interfere with eczema evaluation or safety
- Atopic dermatitis lesions only on hands or feet without involvement of typical areas
- Other types of atopic dermatitis not matching study criteria
- Recent or planned use of systemic or topical treatments that affect atopic dermatitis
- UV light therapy or prolonged artificial UV exposure within 2 weeks before screening or planned during study
- Use of biologic agents within 12 weeks or other systemic immunosuppressive drugs within 4 weeks before Day 1
- Use of systemic antibiotics within 2 weeks or other topical treatments (except bland emollients) within 1 week before Day 1
- Treatment for cancer within 5 years except certain skin cancers and cervical carcinoma in situ
- Active dermatologic conditions other than atopic dermatitis
- Severe or uncontrolled major medical conditions within 3 months
- Systemic infection needing hospitalization within 3 months
- Use of certain parenteral therapies within 3 months
- Significant trauma or major surgery within 3 months prior or planned during study
- Known allergy to zabalafin or its ingredients
- Uncontrolled depression or severe psychiatric conditions
- Positive pregnancy test within 24 hours before randomization for women of childbearing potential
- Live vaccine within 30 days before first dose
- Current or recent use of other investigational drugs within 90 days
- Investigator site staff and their families
- History of alcohol or substance abuse within 6 months
- Any medical or psychiatric condition that could risk participant safety or affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 16 weeks
Participants receive either topical Zabalafin hydrogel or placebo to treat mild to moderate atopic dermatitis.
Visits every 2 weeks for the first month, then monthly until Week 16
Trial Site Locations
Total: 12 locations
1
Canopy Clinical Northern Beaches
Brookvale, New South Wales, Australia, 2100
Actively Recruiting
2
Momentum Clinical Research
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
3
Premier Specialists
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
4
St George Dermatology
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
5
Novatrials
Kotara, New South Wales, Australia, 2289
Actively Recruiting
6
Innovate Clinical Research
Waitara, New South Wales, Australia, 2077
Actively Recruiting
7
Canopy Clinical Wollongong
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
8
The Skin Center
Benowa, Queensland, Australia, 4217
Actively Recruiting
9
Momentum Clinical Research
Wellers Hill, Queensland, Australia, 4012
Actively Recruiting
10
Veracity Clinical Research
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
11
Canopy Clinical Altona North
North Altona, Victoria, Australia, 3025
Actively Recruiting
12
Captain Stirling Medical Centre
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
D
Dr. Lynda Spelman
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here