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NCT05269160 · ClinicalTrials.gov registry record · Phase 1
Topical Dermaprazole for Radiation Dermatitis in Breast Cancer Patients (TOPAZ)
A Phase 1 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT05269160: Clinical Trial Phase 1 study, sponsored by Baylor College of Medicine.
NCT05269160 is a Phase 1 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05269160, a Phase 1 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study 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.
Primary Outcome
A DLT is defined as any of the following:1) Any \> Grade 2 skin toxicity outside the radiation field (Macules/ papules covering 10-30% of the area with or without symptoms of pruritus, burning, tightness); 2). Any \> Grade 2 radiation dermatitis (Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema) within the treatment field that is probably or definitely related to Dermaprazole. Dermatitis will be evaluated by a radiation oncologist o
Interventions
- DRUG Dermaprazole 1%
- DRUG Dermaprazole 2%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2023-04-24 |
| Est. Completion | 2024-04-15 |
| Phase | Phase 1 |
Why NCT05269160 stopped before completion
NCT05269160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Dermaprazole 1% is the first listed.
NCT05269160 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05269160 about?
NCT05269160 is a clinical study titled "Topical Dermaprazole for Radiation Dermatitis in Breast Cancer Patients (TOPAZ)". 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 (P...
What is the current status of trial NCT05269160?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2023-04-24. Estimated completion is 2024-04-15.
What interventions are being tested in trial NCT05269160?
The interventions under investigation include: Dermaprazole 1% (DRUG), Dermaprazole 2% (DRUG).
Who is sponsoring clinical trial NCT05269160?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05269160's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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