ATR04-484 for Acneiform Rash

Recruiting at 3 trial locations

Overseen By Mary Spellman, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Azitra Inc.

Must not be taking: Topical corticosteroids, Systemic antibiotics

Disqualifiers: Significant skin disease, others

Compensation: Varies

Number of Visits: 1

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new topical treatment, ATR04-484, can safely and effectively treat skin rashes caused by EGFR inhibitor therapy, a cancer treatment. Participants will apply either the actual treatment or a placebo (a harmless, inactive substance) daily for 28 days. The trial seeks individuals with moderate to severe skin rashes from EGFR inhibitor therapy, particularly on the face. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

You may need to stop using certain topical or systemic medications before joining the trial. Specifically, you should not have used mid- to high-potency topical corticosteroids, topical antibiotics, antibacterial washes, systemic antibiotics, or systemic corticosteroids within 14 days before starting the trial.

Is there any evidence suggesting that ATR04-484 is likely to be safe for humans?

Studies have shown that ATR04-484 is generally well-tolerated when applied to the skin. Research has focused on its use for skin rashes caused by certain cancer treatments. Early findings suggest that unwanted effects are rare and mild. For example, some users reported minor skin irritation, but serious side effects did not appear in the available data. Researchers continue to study the treatment to ensure its safety and effectiveness, aiming for safe, widespread use in the future. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for acneiform rash, such as antibiotics or retinoids that often come with systemic side effects, ATR04-484 is a topically applied treatment, offering a more localized approach. This new treatment is exciting because it introduces a novel active ingredient specifically designed to target the skin condition directly, potentially reducing inflammation and irritation without affecting the rest of the body. Researchers are optimistic that ATR04-484 could provide an effective and safer alternative for patients who struggle with the side effects of current systemic treatments.

What evidence suggests that ATR04-484 might be an effective treatment for acneiform rash?

Research has shown that ATR04-484, which participants in this trial may receive, might help with skin rashes caused by cancer treatments known as EGFR inhibitors. These rashes are common and can be quite bothersome. ATR04-484 fights certain bacteria, such as Staphylococcus aureus, linked to these rashes. Early findings suggest that ATR04-484 might reduce the severity of these rashes and is safe to use. Although more studies are needed, the initial results are promising for those dealing with these skin reactions. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate to severe skin rash on the face (possibly also neck, chest, back) due to EGFR inhibitor therapy. Participants must not have an infection in the affected areas.

Inclusion Criteria

I have moderate to severe skin reactions from cancer treatment on my face.

Exclusion Criteria

Residing with an immunocompromised person residing with them in the same dwelling from the baseline visit through 2 weeks after the treatment period

I have a skin condition not related to cancer treatment.

I haven't used strong skin creams or antibiotics on my skin or taken them by mouth in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment and Observation

Initial cohort receives a single 4 g application of the study drug followed by a 7-day observation period

1 week

1 visit (in-person)

Extended Treatment

Daily application of ATR04-484 or vehicle for 28 days

4 weeks

Periodic visits for evaluation and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ATR04-484

Trial Overview The study tests if ATR04-484 cream can safely treat skin rashes compared to a non-active cream (vehicle). Patients will use their assigned treatment daily for four weeks and visit the clinic for check-ups and sample collection.

How Is the Trial Designed?

Group I: ATR04-484 Experimental Treatment 1 Intervention

Topically applied ATR04-484

Group II: Vehicle Placebo Group 1 Intervention

Topically applied vehicle

Who Is Running the Clinical Trial?

Azitra Inc.

Lead Sponsor

Trials

4

Recruited

130+

Prosoft Clinical

Collaborator

Trials

9

Recruited

910+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06830863

NCT06830863 | A Study to Evaluate Topical ATR04-484 ... 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) ...

2. curetoday.com curetoday.com/view/phase-1-2-trial-investigating-atr-04-for-egfri-related-rashes-in-lung-cancer

Phase 1/2 Trial Investigating ATR-04 for EGFRi-Related ... These acneiform or rosacea-like eruptions typically appear within days to weeks of treatment, affecting over 90% of patients. The rash often ...

3. withpower.com withpower.com/trial/atr04-484-for-acneiform-rash-fda3e

ATR04-484 for Acneiform Rash This Phase 1 & 2 medical study run by Azitra Inc. is evaluating whether ATR04-484 will have tolerable side effects & efficacy for patients with Acneiform rash.

4. cancernetwork.com cancernetwork.com/view/advancing-treatment-for-egfr-inhibitor-associated-dermal-toxicities

Advancing Treatment for EGFR Inhibitor–Associated ... ATR04-484 showed inhibition of both methicillin-sensitive and methicillin-resistant Staphylococcus aureus bacteria strains, which are associated ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4857844/

Acneiform Rash Induced by EGFR Inhibitors Acneiform rash is the most common side effect of epidermal growth factor receptor (EGFR) inhibitors (EGFRis), and it occurs in 50-100% of patients.

6. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2025.43.16_suppl.TPS12149

Epidermal growth factor receptor (EGFR) inhibitor-induced ... The key objectives of the study are to assess the safety and tolerability of topical ATR04-484 and to evaluate efficacy signals including ...