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

Launched by AZITRA INC. · Feb 12, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to evaluate a new topical treatment called ATR04-484, which aims to help patients who are experiencing skin rashes due to a type of cancer therapy known as EGFR inhibitors. The main goal of the study is to see if ATR04-484 is safe to use and if it can effectively reduce the rash. Participants will apply either ATR04-484 or a placebo (a treatment that looks the same but has no active ingredients) to their skin daily for 28 days and will have regular check-ups at the clinic to monitor their progress.

To join the trial, participants must be adults aged 18 or older and have a moderate to severe rash caused by EGFR inhibitor treatment. However, those with other serious skin conditions or who have recently used certain medications that could affect their skin will not be eligible. This trial is not yet recruiting participants, but if you or someone you know is interested and meets the criteria, it could be an opportunity to help improve treatment for skin rashes associated with cancer therapy.

Gender

ALL

Eligibility criteria

• 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