Actively Recruiting
A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity
Led by Azitra Inc. · Updated on 2026-02-11
32
Participants Needed
6
Research Sites
77 weeks
Total Duration
On this page
Sponsors
A
Azitra Inc.
Lead Sponsor
P
Prosoft Clinical
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Has Grade 2 or 3 non-infected moderate to severe EGFRi-related dermal toxicity affecting the face
- May also have affected areas on the neck, chest, back, or other regions
You will not qualify if you...
- Has significant skin disease other than EGFRi-related dermal toxicity
- Used mid- to high-potency topical corticosteroids or topical antibiotics or antibacterial washes on the face, neck, chest, or back within 14 days before baseline
- Used systemic antibiotics or systemic corticosteroids within 14 days before baseline
- Lives with an immunocompromised person in the same household from baseline through 2 weeks after treatment
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, United States, 71913
Actively Recruiting
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
3
NYU Langone
New York, New York, United States, 10016
Actively Recruiting
4
The Ohio State University
Gahanna, Ohio, United States, 43230
Actively Recruiting
5
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
6
Inova Schar Cancer
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
M
Mary Spellman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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