Actively Recruiting
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
Led by Azitra Inc. · Updated on 2026-02-11
32
Participants Needed
6
Research Sites
4 weeks
Total Duration
On this page
Sponsors
A
Azitra Inc.
Lead Sponsor
P
Prosoft Clinical
Collaborating Sponsor
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 1/2, 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 to 35 days depending on cohort
Participants receive topical applications of ATR04-484 or its vehicle to affected skin areas. The initial cohort applies a single 4 g dose followed by a 7-day observation; they may then continue daily applications for 28 days. A subsequent cohort applies 4 g once daily for 28 days.
Daily applications with clinical assessments during treatment period
Duration - 28 days
Participants are monitored for safety, tolerability, and treatment effects for 28 days after the last application of study drug.
Regular follow-up visits during this period
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
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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