Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer

NCT04865731 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CTMS# 20-0147HSC20210301H
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer of the Head and Neck

Outcome Measures

Primary Outcomes (1)

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

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

  15 months

Study Arms (2)

Dermaprazole

EXPERIMENTAL

30 HNC patients who will be using Dermaprazole twice daily for 7 weeks

Drug: Dermaprazole

Aquaphor

ACTIVE COMPARATOR

15 HNC patients using Aquaphor, the current clinical standard of care

Drug: Aquaphor

Interventions

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.

Also known as: esomeprazole

Dermaprazole

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.

Aquaphor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Mays Cancer Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Esomeprazole; Petrolatum

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons

Results Point of Contact

• Title: Dr. Shraddha Dalwadi
• Organization: University of Texas Health Science Center at San Antonio

dalwadi@uthscsa.edu

210-567-1203

Study Officials

• Shraddha Dalwadi, MD

  The University of Texas Health Science Center - Mays Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: April 29, 2021
• Study Start: June 15, 2022
• Primary Completion: June 18, 2024
• Study Completion: June 18, 2024
• Last Updated: August 6, 2025
• Results First Posted: August 6, 2025

Record last verified: 2025-07

Locations

US (1)