NCT04865731CompletedPhase 2
Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer
A Phase II Clinical Trial of Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer Patients (CTMS# 20-0147)
Source: ClinicalTrials.gov · Last updated 6 Aug 2025
Brief summary (registry, in English)
In this study, the study team seek to conduct a pilot clinical study to evaluate the safety and efficacy of a reformulated proton pump inhibitor (PPI) cream (Dermaprazole) in definitive head and neck cancer (HNC) patients.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 28 Apr 2021
- Start date
- 15 Jun 2022
- Primary completion date
- 18 Jun 2024
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Diseases
- Head and neck cancer
- NCT number
- NCT04865731
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 6
- From 15 Jun 2022 to the primary completion date, 18 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior head and neck radiotherapy
- Neoadjuvant chemotherapy
- Currently taking proton pump inhibitors. Eligible if discontinues with physician approval.
- Lack of concurrent chemotherapy
Other illness
- Any serious medical condition or illness that would preclude the safe administration of the trial treatment including, but not limited to, active infection, symptomatic heart failure, unstable angina, psychiatric illness or social situations that would limit compliance with treatment
- Known autoimmune, connective tissue, or skin disorder; or other theoretical radiosensitivity to include bullous pemphigoid, dermatomyositis, lupus of the skin and scleroderma
Other
- Open wound at time of simulation
Who the study is looking for
- Patients with head and neck malignancy (including radiation therapy to primary head cancers of any histology and/or neck lymphatics, excluding brain malignancies)
- Biopsy proven diagnosis of head and neck malignancy
- Planned to receive definitive chemoradiation of at least 66Gy
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- Written Informed Consent
- History and Physical within 12 weeks of enrollment
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mays Cancer Center Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.