ATR04-484 for Acneiform Rash

Recruiting in New York (>99 mi)

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

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+