Clinical trial · Interventional
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)
NCT04865731CI-TRIAL-00093214completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aquaphor | Drug | — | UNRESOLVED |
| Dermaprazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dermaprazole
- description
- 30 HNC patients who will be using Dermaprazole twice daily for 7 weeks
- interventionNames
- Drug: Dermaprazole
- type
- ACTIVE_COMPARATOR
- label
- Aquaphor
- description
- 15 HNC patients using Aquaphor, the current clinical standard of care
- interventionNames
- Drug: Aquaphor
Primary outcomes (1)
- measure
- Rates of Clinically Significant Radiation Dermatitis as Defined as NCI CTCAE Version 5 Grade 2 or Higher
- timeFrame
- 15 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.