A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity
NCT ID: NCT06830863
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
32 participants
INTERVENTIONAL
2025-08-25
2026-05-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* Apply ATR04-484 or vehicle daily for 28 days
* Visit the clinic periodically for evaluation and sample collection
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate the Safety of ATR-04
NCT04731259
Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis
NCT04975438
Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis
NCT02087943
A Study To Determine The Safety, Tolerability, Skin Irritation Potential, And PK Following Topical Application Of PF-07038124 In Healthy Participants
NCT04135560
A Safety, Tolerability and Preliminary Efficacy Study of FRTX-02 Capsules in Healthy Subjects and Subjects With Atopic Dermatitis
NCT05382819
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The safety, bioavailability, pharmacodynamics (PD), and preliminary effect of ATR04-484 (at a single concentration) will be compared to that of its vehicle, in 2 patient cohorts. In each cohort, eligible patients will be randomized (3:1 ratio) to ATR04-484 or its vehicle. The initial cohort (n = 8) will receive a single 4 g application of the study drug to the face, chest, and back, followed by a 7-day observation period. Upon completion of this observation period, the patients in this cohort may continue in the study with daily applications of study drug for an additional 28 days. Following a safety observation period, a subsequent cohort (n = 24) may be enrolled and will receive a 4 g application of the study drug once daily for 28 days. Each cohort will be followed for 28 days after the last application of study drug.
Clinical assessments of treatment effect will be evaluated at each area that has received a full application of study drug (coverage of all lesional surfaces). The primary endpoint is safety and tolerability. Secondary endpoints including clinical efficacy, including: (1) the severity of the dermal toxicity using a 5-point regional assessment scale, based on modified CTCAE descriptors for skin toxicity (including a score of 0 for clear or unaffected skin through 4 for severely affected skin); (2) numeric rating scales for pruritus and pain; and (3) a quality-of-life assessment (Functional Assessment of Cancer Therapy-EGFRI 18 \[FACT-EGFRI 18\]). Bioavailability of ATR04-484 will also be assessed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ATR04-484
Topically applied ATR04-484
ATR04-484
ATR04-484 is a recombinant live biotherapeutic product (rLBP) containing the engineered S. epidermidis strain SE484 in an ointment formulation for topical use
Vehicle
Topically applied vehicle
Vehicle
Topically applied vehicle.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ATR04-484
ATR04-484 is a recombinant live biotherapeutic product (rLBP) containing the engineered S. epidermidis strain SE484 in an ointment formulation for topical use
Vehicle
Topically applied vehicle.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Prosoft Clinical
OTHER
Azitra Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yale University School of Medicine
New Haven, Connecticut, United States
NYU Langone
New York, New York, United States
The Ohio State University
Gahanna, Ohio, United States
Inova Schar Cancer
Fairfax, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Devon, Clinical Research Coordinator
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ATR04-EGFR-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.