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

Conditions

• EGFR Inhibitor-associated Rash

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ATR04-484 — DRUG
  ATR04-484 is a recombinant live biotherapeutic product (rLBP) containing the engineered S. epidermidis strain SE484 in an ointment formulation for topical use
• Vehicle — DRUG
  Topically applied vehicle.

Study Details

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

Key Dates

Start date

Aug 25, 2025

Status verified

Feb 2026

Primary completion

Jan 15, 2027

Completion

Feb 15, 2027

Study Design

Enrollment

32 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ATR04-484
  Topically applied ATR04-484
• Placebo Comparator: Vehicle
  Topically applied vehicle

Primary Outcome Measure

Safety and tolerability [ Time Frame: 57 days ]

Central Contacts

• Mary Spellman, MD
  415-652-7962
  [email protected]

Locations (6)

Find similar trials in Hot Springs, AR