Trial Outcomes & Findings for Topical Dermaprazole for Radiation Dermatitis in Breast Cancer Patients (TOPAZ) (NCT NCT05269160)
NCT ID: NCT05269160
Last Updated: 2026-02-17
Results Overview
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.
TERMINATED
PHASE1/PHASE2
3 participants
from the first day applying the Dermaprazole cream until 1 month after the subject has completed their last radiation treatment, up to 13 weeks
2026-02-17
Participant Flow
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.
Participant milestones
| Measure |
Dermaprazole 1% (Breast)
Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Dermaprazole 1%: Dermaprazole cream at a concentration of 1% will be applied to the irradiated area twice daily for up to 7 weeks
|
Dermaprazole 2% (Breast)
Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Dermaprazole 2%: Dermaprazole cream at a concentration of 2% will be applied to the irradiated area twice daily for up to 7 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Dermaprazole for Radiation Dermatitis in Breast Cancer Patients (TOPAZ)
Baseline characteristics by cohort
| Measure |
Dermaprazole 1% (Breast)
n=3 Participants
Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Dermaprazole 1%: Dermaprazole cream at a concentration of 1% will be applied to the irradiated area twice daily for up to 7 weeks
|
|---|---|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 8.83 • n=25 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
|
ECOG performance score
0: Fully active, no rrestictions
|
1 Participants
n=25 Participants
|
|
ECOG performance score
1: Restricted in physically strenuous activity
|
2 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: from the first day applying the Dermaprazole cream until 1 month after the subject has completed their last radiation treatment, up to 13 weeksPopulation: Three patients completed the treatment with dermaprazole 1% and no DLT was observed. No more patients were enrolled. The study was terminated before identifing DLT.
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.
Outcome measures
| Measure |
Dermaprazole 1% (Breast)
n=3 Participants
Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Dermaprazole 1%: Dermaprazole cream at a concentration of 1% 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
|
0 Participants
|
PRIMARY outcome
Timeframe: at weekly during radiation treatment, up to 7 weeksPopulation: Not applicable to report the result. Phase II part was not started and the study terminated.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from the first day the subject applies the cream to the end of the 6 month follow up periodThis 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.
Outcome measures
| Measure |
Dermaprazole 1% (Breast)
n=3 Participants
Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Dermaprazole 1%: Dermaprazole cream at a concentration of 1% will be applied to the irradiated area twice daily for up to 7 weeks
|
|---|---|
|
Number of Participants With Grade 2 or Higher Acute Radiation Dermatitis
|
0 participants
|
SECONDARY outcome
Timeframe: from the first day the subject applies the cream to the end of the 6 month follow up periodPopulation: no grade 2 or higher acute radiation dematitis was observed
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from the first day the subject applies the cream to the end of the 6 month follow up periodPopulation: no grade 2 or higher acute radiation dematitis was observed
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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 therapyPatient 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.
Outcome measures
| Measure |
Dermaprazole 1% (Breast)
n=3 Participants
Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Dermaprazole 1%: Dermaprazole cream at a concentration of 1% will be applied to the irradiated area twice daily for up to 7 weeks
|
|---|---|
|
Median of the Peak Score of Total QOL Score
|
34.8 score on a scale
Interval 4.2 to 50.7
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SECONDARY outcome
Timeframe: at weekly during radiation treatment, up to 7 weeksThe number of missing radiation treatments due to skin toxicity will be counted.
Outcome measures
| Measure |
Dermaprazole 1% (Breast)
n=3 Participants
Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Dermaprazole 1%: Dermaprazole cream at a concentration of 1% will be applied to the irradiated area twice daily for up to 7 weeks
|
|---|---|
|
Number of Missed Radiation Treatments Due to Skin Toxicity
|
0 number of missed radiation treatment
|
Adverse Events
Dermaprazole 1% (Breast)
Serious adverse events
| Measure |
Dermaprazole 1% (Breast)
n=3 participants at risk
Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Dermaprazole 1%: Dermaprazole cream at a concentration of 1% will be applied to the irradiated area twice daily for up to 7 weeks
|
|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, puerperium and perinatal conditions - Other, specify
|
33.3%
1/3 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Dermaprazole 1% (Breast)
n=3 participants at risk
Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.
Dermaprazole 1%: Dermaprazole cream at a concentration of 1% will be applied to the irradiated area twice daily for up to 7 weeks
|
|---|---|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Gastritis
|
33.3%
1/3 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • 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.
|
|
Infections and infestations
Vaginal infection
|
33.3%
1/3 • Number of events 1 • 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.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • 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.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Number of events 1 • 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.
|
|
Reproductive system and breast disorders
Menorrhagia
|
33.3%
1/3 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
33.3%
1/3 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
66.7%
2/3 • Number of events 3 • 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.
|
Additional Information
Eunji Jo, Study Statistician
Baylor College of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place