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

NCT05269160 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-02-17

Study results available
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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.

Conditions

Interventions

DRUG

Dermaprazole 1%

Dermaprazole cream at a concentration of 1% will be applied to the irradiated area twice daily for up to 7 weeks

DRUG

Dermaprazole 2%

Dermaprazole cream at a concentration of 2% will be applied to the irradiated area twice daily for up to 7 weeks

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Daniel A Hamstra, MD, PhD · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-24
Primary Completion
2023-06-26
Completion
2024-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05269160 on ClinicalTrials.gov