What is ATR04-484 studying for EGFR inhibitor-associated rash?

ATR04-484 is being studied to evaluate its safety and potential effects on skin rash caused by EGFR inhibitor therapy. This clinical trial aims to understand how well ATR04-484 is tolerated and whether it might improve the skin condition in affected patients.

Who may be eligible for this EGFR inhibitor-associated rash clinical trial?

Adults aged 18 and older with moderate to severe skin rash caused by EGFR inhibitor therapy affecting the face may be eligible. Participants should not have recent use of certain topical or systemic antibiotics or corticosteroids and must not live with immunocompromised individuals. Please review eligibility criteria for more details.

Is there any cost to participate in this EGFR inhibitor-associated rash clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID06830863

Phase 12 Study of Topical ATR04-484 for Moderate to Severe EGFR Inhibitor-Related Skin Rash Evaluating Safety, Drug Absorption, and Effectiveness Compared to Placebo

Led by Azitra Inc. · Updated on 2026-02-11

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and potential effectiveness of a topical treatment called ATR04-484 for patients experiencing moderate to severe skin rash caused by EGFR inhibitor therapy. This Phase 12, multicenter, randomized, and blinded trial compares ATR04-484 to a placebo vehicle in adults with EGFRi-related dermal toxicity primarily affecting the face, and possibly the neck, chest, and back. The study aims to assess the safety, bioavailability, pharmacodynamics, and preliminary treatment effects of ATR04-484. The trial involves two patient cohorts. The first cohort receives a single 4 g application of ATR04-484 or vehicle to the affected areas followed by a 7-day observation period, potentially continuing with daily applications for 28 days. The second cohort receives daily 4 g applications for 28 days. Both cohorts are followed for 28 days after completing treatment. Clinical assessments will evaluate skin toxicity severity, itching, pain, and quality of life using standardized scales. Participants will apply the study treatment daily as directed and attend clinic visits for evaluations and sample collections. Researchers will monitor safety and tolerability as the primary outcome over 57 days, along with secondary measures including skin rash severity, pruritus, and quality of life. Bioavailability of the topical agent will also be assessed. The study duration includes treatment and follow-up periods to thoroughly monitor effects and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults 18 years of age or older
Have Grade 2 or 3 non-infected moderate to severe EGFRi-related skin rash affecting the face
May have affected areas on the neck, chest, back, or other body parts

You will not qualify if you...

Have significant skin disease other than EGFRi-related dermal toxicity
Used mid- to high-potency topical corticosteroids, topical antibiotics, or antibacterial washes on face, neck, chest, or back within 14 days before baseline
Used systemic antibiotics or systemic corticosteroids within 14 days before baseline
Live with an immunocompromised person from baseline through 2 weeks after treatment period

Research Team

Mary Spellman, MD

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