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

NCT06830863 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-02-11

No results posted yet for this study

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

Conditions

  • EGFR Inhibitor-associated Rash

Interventions

DRUG

ATR04-484

ATR04-484 is a recombinant live biotherapeutic product (rLBP) containing the engineered S. epidermidis strain SE484 in an ointment formulation for topical use

DRUG

Vehicle

Topically applied vehicle.

Sponsors & Collaborators

  • Prosoft Clinical

    collaborator OTHER

  • Azitra Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2027-01-15
Completion
2027-02-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06830863 on ClinicalTrials.gov