Phase 2
N=6
Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer
Cancer of the Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT04865731 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Rates of Clinically Significant Radiation Dermatitis as Defined as NCI CTCAE Version 5 Grade 2 or Higher — 3; 1 Number of events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dermaprazole (Drug); Aquaphor (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of Clinically Significant Radiation Dermatitis as Defined as NCI CTCAE Version 5 Grade 2 or Higher |
3; 1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Prior head and neck radiotherapy
- Neoadjuvant chemotherapy
- 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
- Currently taking proton pump inhibitors. Eligible if discontinues with physician approval.
- Lack of concurrent chemotherapy
- Open wound at time of simulation
- Known autoimmune, connective tissue, or skin disorder; or other theoretical radiosensitivity to include bullous pemphigoid, dermatomyositis, lupus of the skin and scleroderma
Data sourced from ClinicalTrials.gov (NCT04865731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.