Radiation DermatitisPhase 1/2NCT05269160
Topical Dermaprazole for Radiation Dermatitis in Breast Cancer Patients (TOPAZ)
A Phase 1/2 study testing Dermaprazole 1% and Dermaprazole 2% in people with Radiation Dermatitis and Breast Cancer, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Radiation Dermatitis, Breast Cancer
- What is being tested?
- Dermaprazole 1% and Dermaprazole 2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Apr 2023to 15 Apr 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with breast cancer, treated with ipsilateral i) Simple (total) mastectomy, OR ii) Modified radical mastectomy, OR iii)Radical mastectomy, OR iv) Segmental mastectomy, OR v) Skin sparing/nipple sparing mastectomy
- Histological diagnosis of invasive ductal or lobular carcinoma (diagnosed within 2 years of enrollment)
- Planned to receive adjuvant chest wall radiation of at least 40Gy or higher biologically equivalent dose (BED)
- Age 18 years or older
- Women of childbearing potential (any woman with menses in the last 12 months) must agree to pregnancy testing and contraceptive use throughout the study period. Testing consists of human chorionic gonadotropin (HCG) urine testing, which if suspected to be falsely positive may be confirmed by ultrasound. If ultrasound is negative, patient is considered not pregnant and eligible for inclusion in the study. In addition to routine contraception method such as barrier devices, hormonal methods, and intrauterine devices, heterosexual celibacy, and surgical sterility (hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or a partner with history of vasectomy) is considered acceptable. If a celibate patient chooses to become sexually active during the study period, she must use one of the listed methods of contraception throughout the study period.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Written Informed Consent
- History and Physical within 12 weeks of enrollment
Who cannot join
- Prior chest wall radiotherapy
- Any serious medical condition or illness that would preclude the safe administration of the study drug including, but not limited to: active infection, symptomatic heart failure, unstable angina, psychiatric illness or social situations that would limit compliance with treatment
- Concurrent chemotherapy
- Biopsy-proven epidermal involvement or positive margins
- Open wound at time of consultation, or delayed surgical wound healing as defined as open wound >8 weeks post-op
- Known active collagen vascular disease such as systemic lupus erythematous, scleroderma or dermatomyositis.
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- Allergy or sensitivity to proton pump inhibitors
- Pregnancy or breast feeding
- Use of clopidrogrel, St. Johns Wort, rifampin, or methotrexate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor St. Luke's Medical Center
Houston, Texas, 77054
Harris Health System - Smith Clinic
Houston, Texas, 77054
About this study
Official title: A Phase I/II Study of Dermaprazole For Radiation Dermatitis in Post-Mastectomy Breast Cancer Patients.
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.
Read the detailed description
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.
- Conditions
- Radiation Dermatitis, Breast Cancer
- Being tested
- Dermaprazole 1%, Dermaprazole 2%
- Keywords
- Radiation dermatitis, post-mastectomy, radiation therapy, breast cancer
- Medical subject headings
- Radiodermatitis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermaprazole 1%Drug
Dermaprazole cream at a concentration of 1% will be applied to the irradiated area twice daily for up to 7 weeks
Dermaprazole 2%Drug
Dermaprazole cream at a concentration of 2% will be applied to the irradiated area twice daily for up to 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dermaprazole 1% (Breast) | Experimental | Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period. Receives: Drug: Dermaprazole 1% |
| Dermaprazole 2% (Breast) | Experimental | Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period. Receives: Drug: Dermaprazole 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at weekly during radiation treatment, up to 7 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at weekly during radiation treatment, up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start24 Apr 2023
- Primary completion26 Jun 2023
- Study completion15 Apr 2024
Why it stopped: PI is leaving institution and this protocol will not be further pursued at this institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Hamstra, Baylor College of Medicine
- Investigators
- Daniel A Hamstra, MD, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269160
- Sponsor's protocol ID
- H-45698
- Status last verified
- Jul 2025
- First submitted
- 25 Feb 2022
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Dermaprazole For Radiation Dermatitis in Post-Mastectomy Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT05269160
- Acronym / sponsor ID
- H-45698
- Conditions
- Radiation Dermatitis, Breast Cancer
- Keywords
- Radiation dermatitis, post-mastectomy, radiation therapy, breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI is leaving institution and this protocol will not be further pursued at this institution.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Posted 17 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dermaprazole 1% (Breast) | Experimental | Drug: Dermaprazole 1%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 2% (Breast) | Experimental | Drug: Dermaprazole 2%Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women with breast cancer, treated with ipsilateral i) Simple (total) mastectomy, OR ii) Modified radical mastectomy, OR iii)Radical mastectomy, OR iv) Segmental mastectomy, OR v) Skin sparing/nipple sparing mastectomy
- Histological diagnosis of invasive ductal or lobular carcinoma (diagnosed within 2 years of enrollment)
- Planned to receive adjuvant chest wall radiation of at least 40Gy or higher biologically equivalent dose (BED)
- Age 18 years or older
- Women of childbearing potential (any woman with menses in the last 12 months) must agree to pregnancy testing and contraceptive use throughout the study period. Testing consists of human chorionic gonadotropin (HCG) urine testing, which if suspected to be falsely positive may be confirmed by ultrasound. If ultrasound is negative, patient is considered not pregnant and eligible for inclusion in the study. In addition to routine contraception method such as barrier devices, hormonal methods, and intrauterine devices, heterosexual celibacy, and surgical sterility (hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or a partner with history of vasectomy) is considered acceptable. If a celibate patient chooses to become sexually active during the study period, she must use one of the listed methods of contraception throughout the study period.
Key exclusion criteria (9 listed)
- Prior chest wall radiotherapy
- Any serious medical condition or illness that would preclude the safe administration of the study drug including, but not limited to: active infection, symptomatic heart failure, unstable angina, psychiatric illness or social situations that would limit compliance with treatment
- Concurrent chemotherapy
- Biopsy-proven epidermal involvement or positive margins
- Open wound at time of consultation, or delayed surgical wound healing as defined as open wound >8 weeks post-op
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermaprazole 1%Dermaprazole cream at a concentration of 1% will be applied to the irradiated area twice daily for up to 7 weeks | Drug | Dermaprazole 1% (Breast) |
| Dermaprazole 2%Dermaprazole cream at a concentration of 2% will be applied to the irradiated area twice daily for up to 7 weeks | Drug | Dermaprazole 2% (Breast) |
Primary outcome
Number of Participants With Dose-Limiting Toxicity(DLT) in Phase I
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
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.
Rate of Clinically Bothersome Radiation Dermatitis at Maximum Feasible Dose in Phase II
Time frame: at weekly during radiation treatment, up to 7 weeks
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.
5 secondary outcomes
Number of Participants With 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- Occurrence Time 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
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
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
Time frame: at weekly during radiation treatment, up to 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel A Hamstra, MD, PhD principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dermaprazole 1% and Dermaprazole 2% in people with Radiation Dermatitis and Breast Cancer, run by Baylor College of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-Limiting Toxicity(DLT) in Phase I (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.