drugset / Trial / NCT05269160

Topical Dermaprazole for Radiation Dermatitis in Breast Cancer Patients (TOPAZ)

NCT05269160

Phase 1/2 Terminated 3 enrolled Baylor College of Medicine
Non-randomizedSequentialOpen-labelSupportive care

Summary

Radiotherapy is a mainstay of treatment in breast cancer treatment, in the adjuvant setting. Radiation dermatitis occurs in up to 65% of these patients; currently, there is no standard of care for this treatment-related toxicity. The aim of this study is to investigate the safety and tolerability (Phase I) and preliminary efficacy (Phase II) of prophylactic esomeprazole cream (termed "Dermaprazole") in patients who require radiation for breast cancer in the adjuvant setting.

Timeline

Start
2023-04-24
Primary completion
2023-06-26
Completion
2024-04-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Esomeprazole Small molecule 1 % Topical
Subject Esomeprazole Small molecule 2 % Topical