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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

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* 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 Criteria:

* 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

About the study

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

What is being tested

• ATR04-484 (drug)
• Vehicle (drug)

Sponsor: Azitra Inc. · Participants: 32 · Started: Aug 25, 2025

Contact the study team

• Mary Spellman, MD · Phone: 415-652-7962

Official record on ClinicalTrials.gov — NCT06830863

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.