A Phase 2 interventional study of Dermaprazole and Aquaphor in Cancer of the Head and Neck, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-06.
Sponsored by The University of Texas Health Science Center at San Antonio · Phase 2, Interventional, and Treatment
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.
This study's enrollment of 6 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
30 HNC patients who will be using Dermaprazole twice daily for 7 weeks
Drug: Dermaprazole
15 HNC patients using Aquaphor, the current clinical standard of care
Drug: Aquaphor
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
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.
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
Time frame: 15 months
| Milestone | Dermaprazole | Aquaphor |
|---|---|---|
| Started | 4 | 2 |
| Completed | 1 | 0 |
| Not completed | 3 | 2 |
| Withdrew: Physician decision | 2 | 1 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Number of radiation dermatitis adverse events defined by the NCI CTCAE version 5 that are graded as 2 or higher
| Number of events | Dermaprazole | Aquaphor |
|---|---|---|
| Rates of Clinically Significant Radiation Dermatitis as Defined as NCI CTCAE Version 5 Grade 2 or Higher | 3 | 1 |
Collected over Baseline to 15 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dermaprazole | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Aquaphor | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Event | Dermaprazole | Aquaphor |
|---|---|---|
| Dermatitis radiationSkin and subcutaneous tissue disorders | 4/4 | 2/2 |
| Dry mouthGastrointestinal disorders | 3/4 | 2/2 |
| DysgeusiaGastrointestinal disorders | 4/4 | 1/2 |
| FatigueGeneral disorders | 4/4 | 1/2 |
| Mucositis oralGastrointestinal disorders | 4/4 | 2/2 |
| NauseaGastrointestinal disorders | 4/4 | 2/2 |
| Sore throatRespiratory, thoracic and mediastinal disorders | 4/4 | 1/2 |
| Allergic reactionImmune system disorders | 0/4 | 2/2 |
| DysphagiaGastrointestinal disorders | 3/4 | 1/2 |
| Weight lossGastrointestinal disorders | 3/4 | 1/2 |
Participants receiving radiation therapy
| Age, Categorical(Participants) | Dermaprazole | Aquaphor | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 1 | 4 |
| >=65 years | 1 | 1 | 2 |
| Sex: Female, Male(Participants) | Dermaprazole | Aquaphor | Total |
|---|---|---|---|
| Female | 2 | 0 | 2 |
| Male | 2 | 2 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Dermaprazole | Aquaphor | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 4 | 2 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Dermaprazole | Aquaphor | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 2 | 2 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(participants) | Dermaprazole | Aquaphor | Total |
|---|---|---|---|
| United States | 4 | 2 | 6 |
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The University of Texas Health Science Center at San Antonio