A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity
Recruiting now · Phase 1/Phase 2
Conditions studied: EGFR Inhibitor-associated Rash
In brief
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
Key facts
- Study ID
- NCT06830863
- Run by
- Azitra Inc.
- People needed
- 32
- Starts
- 2025-08-25
- Expected to finish
- 2027-02-15
- Last updated by the study team
- 2026-02-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Genesis Cancer and Blood Institute — Hot Springs, Arkansas, United States (enrolling)
- Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
- NYU Langone — New York, New York, United States (enrolling)
- The Ohio State University — Gahanna, Ohio, United States (enrolling)
- MD Anderson — Houston, Texas, United States (enrolling)
- Inova Schar Cancer — Fairfax, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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