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RecruitingPhase 1/Phase 2

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

Azitra Inc. · with Prosoft Clinical · NCT06830863

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
32
US sites recruiting
6
Study start
August 25, 2025
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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

Being studied: ATR04-484; Vehicle

Conditions: EGFR Inhibitor-associated Rash

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Adults ≥18 years of age
  • Currently treated with an FDA-approved EGFRi, KRASi, or MEKi (or other medications in the pathway, if approved by the Medical Monitor) for the treatment of cancer with or without concurrent chemotherapy, or for neurofibromatosis, and expected to continue treatment with the medication through the study treatment period
  • Has Grade 2 or 3 non-infected moderate to severe dermal toxicity affecting the face (the neck, chest, back and other areas may also be affected); Grade 1 toxicity may be permitted in up to 25% of enrolled patients

Exclusion Criteria

  • Significant skin disease other than EGFRi-related dermal toxicity
  • Treatment with topical mid- to high-potency topical corticosteroids, or topical antibiotics or antibacterial washes on the face, neck, chest, or back within 7 days prior to baseline; treatment with systemic antibiotics or systemic corticosteroids within 7 days prior to baseline
  • Residing with an immunocompromised person residing with them in the same dwelling from the baseline visit through 2 weeks after the treatment period

Recruiting US locations

  • Genesis Cancer and Blood Institute

    Hot Springs, AR 71913

    Site contact: Laura, · 501-624-7700 · Laura.Sellers@aoncology.com

  • Yale University School of Medicine

    New Haven, CT 06510

    Site contact: Rehema, Clinical Research Coordinator · 203-785-2270

  • NYU Langone

    New York, NY 10016

    Site contact: Sevinj, Sr. Clinical Research Coordinator · 212-263-5244 · Sevinj.Sasunova@nyulangone.org

  • The Ohio State University

    Gahanna, OH 43230

    Site contact: Elizabeth, Clinical Research Coordinator · 614-293-9306 · Elizabeth.Begle@osumc.edu

  • MD Anderson

    Houston, TX 77030

    Site contact: Angelica, Sr. Coordinator, Clinical Research · 832-846-0794 · ARRodriguez3@mdanderson.org

  • Inova Schar Cancer

    Fairfax, VA 22031

    Site contact: Stephanie, Senior Director, Clinical Trials Office · 571-472-4724 · Stephanie.vanbebber@inova.org

Study contacts (from the official record)

  • Mary Spellman, MD · 415-652-7962 · spellman@azitrainc.com
All phase 1 studies in Arkansas →
A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal… (NCT06830863) | Bored Studies