Topical treatment for skin rash caused by EGFR inhibitors

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

This study is testing a new cream to see if it can help people with moderate to severe skin rashes caused by EGFR inhibitor therapy feel better.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Azitra Inc. (Industry-sponsored)
• Locations: 6 sites (Hot Springs, Arkansas and 5 other locations)
• Trial ID: NCT06830863 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of a topical treatment called ATR04-484 for patients experiencing moderate to severe skin rash due to EGFR inhibitor therapy. Participants will apply ATR04-484 or a placebo vehicle daily for 28 days while attending periodic clinic visits for assessments and sample collection. The study is designed as a multicenter, randomized, and blinded trial, comparing the treatment's effects on skin toxicity across different body areas. The primary focus is on safety and tolerability, with secondary goals assessing clinical efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate to severe EGFR inhibitor-related dermal toxicity.

Not a fit: Patients with significant skin diseases other than EGFR inhibitor-related toxicity or those on certain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate skin rash symptoms for patients undergoing EGFR inhibitor therapy.

How similar studies have performed: Other studies have explored topical treatments for similar conditions, but this specific approach with ATR04-484 is novel.

Eligibility criteria

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

Where this trial is running

Hot Springs, Arkansas and 5 other locations

• Genesis Cancer and Blood Institute — Hot Springs, Arkansas, United States (Recruiting)
• Yale University School of Medicine — New Haven, Connecticut, United States (Recruiting)
• NYU Langone — New York, New York, United States (Recruiting)
• The Ohio State University — Gahanna, Ohio, United States (Recruiting)
• MD Anderson — Houston, Texas, United States (Recruiting)
• Inova Schar Cancer — Fairfax, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Mary Spellman, MD

Conditions EGFR Inhibitor-associated Rash; EGFR; acneiform; EGFR inhibitor-associated rash; EGFRi