RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-06-15
Study Completion:2026-03-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06830863

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults ≥18 years of age
  2. * 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)
  1. * Significant skin disease other than EGFRi-related dermal toxicity
  2. * 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
  3. * Residing with an immunocompromised person residing with them in the same dwelling from the baseline visit through 2 weeks after the treatment period

Contacts and Locations

Study Contact

Mary Spellman, MD
CONTACT
415-652-7962
clinicaltrials@azitrainc.com

Study Locations (Sites)

NYU Langone
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: Azitra Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-15
Study Completion Date2026-03-13

Study Record Updates

Study Start Date2025-06-15
Study Completion Date2026-03-13

Terms related to this study

Keywords Provided by Researchers

  • EGFR
  • acneiform
  • EGFR inhibitor-associated rash
  • EGFRi

Additional Relevant MeSH Terms

  • EGFR Inhibitor-associated Rash