Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer

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.

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Key information

Conditions

Cancer of the Head and Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mays Cancer Center

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dermaprazole

Drug

Patients will be managed with twice daily prophylactic use of the proposed intervention (Dermaprazole) topical cream for radiation dermatitis. The amount of cream will be 2cc per application and will be measured in pre-filled capped syringes for every application.

Other names: esomeprazole

Aquaphor

Drug

Patients will be managed with twice daily prophylactic use of Aquaphor. The amount of Aquaphor will be 2cc per application and will be measured in pre-filled capped syringes for every application.

Primary outcomes

Rates of Clinically Significant Radiation Dermatitis as Defined as NCI CTCAE Version 5 Grade 2 or Higher

Time frame: 15 months

Number of radiation dermatitis adverse events defined by the NCI CTCAE version 5 that are graded as 2 or higher

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

A Phase II Clinical Trial of Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer Patients (CTMS# 20-0147)

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Apr 29, 2021
Registry last updated: Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed