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๐Ÿ›๏ธ Verified NIH Protocol โ€ข Sourced via U.S. National Library of Medicine (Last Synced: 2026-02-11)

A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity

๐ŸŸข Recruiting Phase 1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Azitra Inc.

๐Ÿฉบ Protocol 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

Primary Research Facility: Genesis Cancer and Blood Institute (Hot Springs, Arkansas)

๐Ÿ“‹ Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

๐Ÿ“ Primary Site Map

Site: Genesis Cancer and Blood Institute โ€” Hot Springs, Arkansas

๐Ÿ“ All Participating Trial Locations (6 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Genesis Cancer and Blood Institute โ€” Hot Springs, Arkansas โ€ข Contact: (501) 624-7700
2. Yale University School of Medicine โ€” New Haven, Connecticut โ€ข Contact: (203) 785-2270
3. NYU Langone โ€” New York, New York โ€ข Contact: (212) 263-5244
4. The Ohio State University โ€” Gahanna, Ohio โ€ข Contact: (614) 293-9306
5. MD Anderson โ€” Houston, Texas โ€ข Contact: (832) 846-0794
6. Inova Schar Cancer โ€” Fairfax, Virginia โ€ข Contact: (571) 472-4724

๐Ÿ“„ Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

๐Ÿ’ฐ Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act ยง 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

๐Ÿ’ก Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

๐Ÿ›๏ธ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT06830863 โ€ข Last Synced: 2026-02-11
View on ClinicalTrials.gov โ†—
๐Ÿ“ž Call Desk ๐Ÿ“‹ Check Criteria