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New Bacteria-Based cream aims to soothe cancer drug rash

NCT ID NCT06830863

Symptom relief Sponsor: Azitra Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a cream called ATR04-484 for treating moderate to severe skin rash that can happen when taking EGFR inhibitor cancer drugs. The cream contains a specially engineered bacteria. 32 adults will apply the cream or a placebo daily for 28 days to see if it is safe and helps clear the rash.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ATR04-484, a cream containing engineered bacteria
What this could lead to
If it works, this could provide a new topical treatment for the painful skin rash caused by certain cancer drugs.
What could go wrong
This is an early phase 1/2 trial with only 32 people, so results may not apply to everyone. The cream may not work better than the placebo (vehicle) cream.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults ≥18 years of age * 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) 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 14 days prior to baseline; treatment with systemic antibiotics or systemic corticosteroids within 14 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

EGFR inhibitor-associated rash

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Genesis Cancer and Blood Institute

    RECRUITING

    Hot Springs, Arkansas, 71913, United States

  • Inova Schar Cancer

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • MD Anderson

    RECRUITING

    Houston, Texas, 77030, United States

  • NYU Langone

    RECRUITING

    New York, New York, 10016, United States

  • The Ohio State University

    RECRUITING

    Gahanna, Ohio, 43230, United States

  • Yale University School of Medicine

    RECRUITING

    New Haven, Connecticut, 06510, United States