A Phase 1/2 interventional study of Dermaprazole 1% and Dermaprazole 2% in Radiation Dermatitis and Breast Cancer, sponsored by Baylor College of Medicine. Terminated at 2 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Baylor College of Medicine · Phase 1/2, Interventional, and Supportive care
Radiotherapy is a mainstay of treatment in breast cancer treatment, in the adjuvant setting. Radiation dermatitis occurs in up to 65% of these patients; currently, there is no standard of care for this treatment-related toxicity. The aim of this study is to investigate the safety and tolerability (Phase I) and preliminary efficacy (Phase II) of prophylactic esomeprazole cream (termed "Dermaprazole") in patients who require radiation for breast cancer in the adjuvant setting.
All study participants will begin using Dermaprazole for 1-2 weeks prior to receiving radiation. During the CT Simulation, study participants will be instructed to apply Dermaprazole in a "patch test" area - an area of the chest outside of the field of radiation. This is to assess for immediate skin reactions including itching, irritation and allergy. If there are no immediate allergic reactions at the conclusion of the simulation visit, the study participant will be instructed to apply the cream in the patch test for 2-4 days to assess for contact dermatitis and if no itching or rash at that time (evaluation will be conducted via phone call). Patients will be questioned regarding any visible skin changes or irritation (itching, peeling, scaling), and patients responding in the affirmative will be asked to present for clinic visit or send photographs for visual classification according to the scale outlines in Table 1 below. Skin reactions matching a score of 3 will be evaluated with a second clinic visit between 2 to 7 days after initial application. Any skin reactions of score 4 or 5 at final assessment will be deemed to be positive for allergic contact dermatitis, and patients will be deemed positive for allergic contact dermatitis.
Two dose levels of Dermaprazole (1% and 2%) will be evaluated in the combination Phase I/II dose escalation/de-escalation BOIN design study evaluating preliminary efficacy at the Maximum Feasible Dose (MFD). The Dermaprazole will be initiated at a dose of 1% and escalated to 2% as appropriate based on the number of adverse events. A Dose Limiting Toxicity (DLT) will be defined as any of the following: a) any > Grade 2 skin toxicity outside the radiation field (Macules/ papules covering 10-30% of the area with or without symptoms of pruritus, burning, tightness), b) any > Grade 2 radiation dermatitis (Moderate to brisk erythema; patchy moist desquamation, within the radiation field that is probably or definitely related to Dermaprazole. Dermatitis will be evaluated by a radiation oncologist on a weekly basis using the Common Terminology Criteria for Adverse Events (CTCAE) V5.0 criteria. Patient reported quality of life will be evaluated using a validated survey instrument called SkinDex16.
134 studies on the registry are indexed under Radiodermatitis; 26 are open to participants now.
This study's enrollment of 3 is below the median of 58 across 109 interventional studies indexed under Radiodermatitis.
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Exclusion Criteria:
Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Drug: Dermaprazole 1%
Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Drug: Dermaprazole 2%
Dermaprazole cream at a concentration of 1% will be applied to the irradiated area twice daily for up to 7 weeks
Dermaprazole cream at a concentration of 2% will be applied to the irradiated area twice daily for up to 7 weeks
Number of Participants With Dose-Limiting Toxicity(DLT) in Phase I
A DLT is defined as any of the following:1) Any \> Grade 2 skin toxicity outside the radiation field (Macules/ papules covering 10-30% of the area with or without symptoms of pruritus, burning, tightness); 2). Any \> Grade 2 radiation dermatitis (Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema) within the treatment field that is probably or definitely related to Dermaprazole. Dermatitis will be evaluated by a radiation oncologist on a weekly basis using the Common Terminology Criteria for Adverse Events (CTCAE) V5.0 criteria. Patient reported quality of life will be evaluated using a validated survey instrument called SkinDex16.
Time frame: from the first day applying the Dermaprazole cream until 1 month after the subject has completed their last radiation treatment, up to 13 weeks
Rate of Clinically Bothersome Radiation Dermatitis at Maximum Feasible Dose in Phase II
Radiation dermatitis will be determined by the radiation oncologist and defined using NCI Common Terminology Criteria for Adverse Events (CTCAE version 5) for dermatitis radiation. In particular, the individual components of radiation dermatitis will be recorded: erythema, desquamation, edema, bleeding, skin necrosis and skin ulceration.
Time frame: at weekly during radiation treatment, up to 7 weeks
Number of Participants With Grade 2 or Higher Acute Radiation Dermatitis
This measure reports the number of participants who experienced Grade 2 or higher acute radiation dermatitis, as defined by the maximum observed severity during the treatment period. In particular, the individual components of radiation dermatitis will be recorded: erythema, desquamation, edema, bleeding, skin necrosis and skin ulceration.
Time frame: from the first day the subject applies the cream to the end of the 6 month follow up period
Median- Occurrence Time of Grade 2 or Higher Acute Radiation Dermatitis
Median-occurrence of grade 2 or higher acute radiation dermatitis time on the Kaplan-Meier method is defined as the time between the first time of applying the cream and the time of occurrence of grade 2 or higher acute radiation dermatitis.
Time frame: from the first day the subject applies the cream to the end of the 6 month follow up period
Median-healing Time of Grade 2 or Higher Acute Radiation Dermatitis Develops
Median-healing time of grade 2 or higher acute radiation dermatitis developing time on the Kaplan-Meier method is defined from time to develop the grade 2 or higher acute radiation dermatitis after applying the cream to healing the event.
Time frame: from the first day the subject applies the cream to the end of the 6 month follow up period
Median of the Peak Score of Total QOL Score
Patient reported quality of life will be evaluated using a validated survey instrument called SkinDex16 questionnaire for QOL. The Skindex-16 assessment tool is designed to capture patient-reported assessments of subjective adverse effects. It consists of a short 16-item assessment completed by the patient, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). The total raw scores are transformed to a 0 - 100 scale. The higher scores indicate greater impairment. For each patient, identifiy the highest total QOL score across all time points, and then calcuate the median of these individual peak scores across all patients.
Time frame: at before and after Dermaprazole cream application at the CT simulation visit, weekly during radiation treatment up to 7 weeks, 1 and 6 month follow-up after completion of all radiation therapy
Number of Missed Radiation Treatments Due to Skin Toxicity
The number of missing radiation treatments due to skin toxicity will be counted.
Time frame: at weekly during radiation treatment, up to 7 weeks
The study started with the phase I part to define the safety and maximum feasible dose of Dermaprazole(two dose levels: 1% and 2%). Three patients applied dose level of 1% and completed treatment and follow up. No more patients were enrolled.
| Milestone | Dermaprazole 1% (Breast) | Dermaprazole 2% (Breast) |
|---|---|---|
| Started | 3 | 0 |
| Completed | 3 | 0 |
| Not completed | 0 | 0 |
A DLT is defined as any of the following:1) Any \> Grade 2 skin toxicity outside the radiation field (Macules/ papules covering 10-30% of the area with or without symptoms of pruritus, burning, tightness); 2). Any \> Grade 2 radiation dermatitis (Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema) within the treatment field that is probably or definitely related to Dermaprazole. Dermatitis will be evaluated by a radiation oncologist on a weekly basis using the Common Terminology Criteria for Adverse Events (CTCAE) V5.0 criteria. Patient reported quality of life will be evaluated using a validated survey instrument called SkinDex16.
| Participants | Dermaprazole 1% (Breast) |
|---|---|
| Number of Participants With Dose-Limiting Toxicity(DLT) in Phase I | 0 |
Radiation dermatitis will be determined by the radiation oncologist and defined using NCI Common Terminology Criteria for Adverse Events (CTCAE version 5) for dermatitis radiation. In particular, the individual components of radiation dermatitis will be recorded: erythema, desquamation, edema, bleeding, skin necrosis and skin ulceration.
No measurements were reported for this outcome.
This measure reports the number of participants who experienced Grade 2 or higher acute radiation dermatitis, as defined by the maximum observed severity during the treatment period. In particular, the individual components of radiation dermatitis will be recorded: erythema, desquamation, edema, bleeding, skin necrosis and skin ulceration.
| participants | Dermaprazole 1% (Breast) |
|---|---|
| Number of Participants With Grade 2 or Higher Acute Radiation Dermatitis | 0 |
Median-occurrence of grade 2 or higher acute radiation dermatitis time on the Kaplan-Meier method is defined as the time between the first time of applying the cream and the time of occurrence of grade 2 or higher acute radiation dermatitis.
No measurements were reported for this outcome.
Median-healing time of grade 2 or higher acute radiation dermatitis developing time on the Kaplan-Meier method is defined from time to develop the grade 2 or higher acute radiation dermatitis after applying the cream to healing the event.
No measurements were reported for this outcome.
Patient reported quality of life will be evaluated using a validated survey instrument called SkinDex16 questionnaire for QOL. The Skindex-16 assessment tool is designed to capture patient-reported assessments of subjective adverse effects. It consists of a short 16-item assessment completed by the patient, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). The total raw scores are transformed to a 0 - 100 scale. The higher scores indicate greater impairment. For each patient, identifiy the highest total QOL score across all time points, and then calcuate the median of these individual peak scores across all patients.
| score on a scale | Dermaprazole 1% (Breast) |
|---|---|
| Median of the Peak Score of Total QOL Score | 34.8 (4.2 to 50.7) |
The number of missing radiation treatments due to skin toxicity will be counted.
| number of missed radiation treatment | Dermaprazole 1% (Breast) |
|---|---|
| Number of Missed Radiation Treatments Due to Skin Toxicity | 0 |
Collected over The AE collection/reporting period will begin with the first day of application of Dermaprazole and will end 30 days after radiation, up to 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dermaprazole 1% (Breast) | 0/3 (0%) | 1/3 (33.3%) | 3/3 (100%) |
| Event | Dermaprazole 1% (Breast) |
|---|---|
| Pregnancy, puerperium and perinatal conditions - Other, specifyPregnancy, puerperium and perinatal conditions | 1/3 |
| Event | Dermaprazole 1% (Breast) |
|---|---|
| Skin and subcutaneous tissue disorders - Other, specifySkin and subcutaneous tissue disorders | 2/3 |
| Endocrine disorders - Other, specifyEndocrine disorders | 1/3 |
| GastritisGastrointestinal disorders | 1/3 |
| NauseaGastrointestinal disorders | 1/3 |
| VomitingGastrointestinal disorders | 1/3 |
| Vaginal infectionInfections and infestations | 1/3 |
| HeadacheNervous system disorders | 1/3 |
| Peripheral sensory neuropathyNervous system disorders | 1/3 |
| MenorrhagiaReproductive system and breast disorders | 1/3 |
| ErythrodermaSkin and subcutaneous tissue disorders | 1/3 |
| Age, Continuous(years) | Dermaprazole 1% (Breast) |
|---|---|
| Mean | 38 ± 8.83 |
| Sex: Female, Male(Participants) | Dermaprazole 1% (Breast) |
|---|---|
| Female | 3 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Dermaprazole 1% (Breast) |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 0 |
| ECOG performance score(Participants) | Dermaprazole 1% (Breast) |
|---|---|
| 0: Fully active, no rrestictions | 1 |
| 1: Restricted in physically strenuous activity | 2 |
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Baylor College of Medicine