A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity
A Phase 1/2, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety, Bioavailability, and Effect of Topically Administered ATR04-484 for Moderate to Severe EGFRi-Associated Dermal Toxicity
Azitra Inc.
32 participants
Aug 25, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this randomized clinical trial is to learn if topical treatment with ATR04-484 can treat skin rash in patients undergoing EGFR inhibitor (EGFRi) therapy. The primary goal of the study is to determine safety and tolerability of ATR04-484, and the secondary goal of the study is to assess efficacy signals of ATR04-484. Researchers will compare treatment of ATR04-484 to its vehicle. Participants will: * Apply ATR04-484 or vehicle daily for 28 days * Visit the clinic periodically for evaluation and sample collection
Eligibility
Inclusion Criteria2
- Adults ≥18 years of age
- Has Grade 2 or 3 non-infected moderate to severe EGFRi-related dermal toxicity affecting the face (the neck, chest, back and other areas may also be affected)
Exclusion Criteria3
- Significant skin disease other than EGFRi-related dermal toxicity
- Treatment with topical mid- to high-potency topical corticosteroids, or topical antibiotics or antibacterial washes on the face, neck, chest, or back within 14 days prior to baseline; treatment with systemic antibiotics or systemic corticosteroids within 14 days prior to baseline
- Residing with an immunocompromised person residing with them in the same dwelling from the baseline visit through 2 weeks after the treatment period
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Interventions
ATR04-484 is a recombinant live biotherapeutic product (rLBP) containing the engineered S. epidermidis strain SE484 in an ointment formulation for topical use
Topically applied vehicle.
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT06830863