Topical Dermaprazole for Radiation Skin Damage in Cancer Patients

Recruiting at 2 trial locations

Overseen By Michelle S Ludwig, MD, MPH, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Michelle S Ludwig

Must not be taking: Clopidogrel, St. Johns Wort

Disqualifiers: Prior radiotherapy, Active infection, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

37 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new cream, Dermaprazole, to help prevent skin damage from radiation therapy in breast cancer patients. Researchers aim to determine if this cream is safe, tolerable, and potentially effective in reducing radiation-related skin issues. Participants will apply either a 1% or 2% concentration of the cream twice daily during their treatment. Women who have undergone certain types of breast cancer surgeries and are scheduled for radiation therapy might be suitable for this study. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial group, offering participants a chance to contribute to important advancements in skin care during cancer treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, specifically clopidogrel, St. John's Wort, rifampin, or methotrexate. If you are on any of these, you will need to discontinue them to participate.

Is there any evidence suggesting that Dermaprazole is likely to be safe for humans?

Research has shown that Dermaprazole cream, used to treat skin damage from radiation, appears safe. The cream is being tested in two strengths: 1% and 2%. Studies have found that patients using similar creams for radiation-related skin irritation generally tolerate them well, with no reports of serious side effects so far.

The current trials are in the early stages, focusing on ensuring the treatment's safety for people. This phase identifies any possible side effects and assesses how well patients handle the treatment. The results so far are promising, indicating that Dermaprazole is well-tolerated when applied to the skin. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Dermaprazole because it offers a novel approach to managing radiation skin damage, a common issue for cancer patients undergoing treatment. Unlike standard options such as corticosteroid creams, Dermaprazole is a topical cream that potentially reduces skin damage through its unique formulation. It comes in two concentrations, 1% and 2%, which allows for tailored treatment based on the severity of skin damage. This dual-concentration approach could offer more flexibility and effectiveness compared to one-size-fits-all treatments, making it an appealing new option in supportive cancer care.

What evidence suggests that Dermaprazole might be an effective treatment for radiation skin damage?

Research has shown that Dermaprazole cream may help treat skin damage from radiation. Animal studies found that it can improve skin health after radiation exposure. Dermaprazole appears to protect the skin from radiation damage. In this trial, participants will receive either a 1% or 2% concentration of Dermaprazole cream. Early results for both concentrations suggest it might lower the risk of radiation dermatitis (skin irritation from radiation) in cancer patients. While these results are promising, more research is needed to confirm its effectiveness in humans. ^{1 3 4 5 6}

Who Is on the Research Team?

Michelle S Ludwig, MD, MPH, PhD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

The TOPAZ trial is for adults with head and neck cancer or breast cancer who are undergoing radiation therapy. Eligible participants include those with specific types of these cancers, confirmed within the last 2 years, and planned to receive a certain dose of radiation. They must be in good enough health to participate as judged by their ECOG status. People can't join if they have had prior radiotherapy in the same area, are pregnant or breastfeeding, have certain medical conditions like active infections or collagen vascular diseases, allergies to proton pump inhibitors, or use specific medications.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

Arm B: History and Physical within 12 weeks of enrollment

Arm B: Written Informed Consent

Exclusion Criteria

My biopsy shows cancer on the skin or at the edge of the surgery area.

I do not have any serious conditions that would make the study drug unsafe for me.

You are allergic or sensitive to proton pump inhibitors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-Radiation Preparation

Participants apply Dermaprazole in a patch test area to assess for immediate skin reactions

1-2 weeks

1 visit (in-person)

Radiation Treatment

Participants apply Dermaprazole daily during radiotherapy and are monitored for adverse events

up to 7 weeks

Weekly visits (in-person)

Post-Radiation Treatment

Participants continue Dermaprazole application for 2 weeks after completing radiation treatment

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1 and 6 month follow-up visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dermaprazole

Trial Overview This study tests Dermaprazole cream at two different strengths (1% and 2%) for preventing skin damage caused by radiation therapy in patients with breast cancer post-mastectomy or head and neck cancer. The trial aims to assess how safe and tolerable this treatment is (Phase I) as well as its initial effectiveness (Phase II).

How Is the Trial Designed?

Group I: Dermaprazole 2% (Breast) Experimental Treatment 1 Intervention

Dermaprazole cream at a concentration of 2% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.

Group II: Dermaprazole 1% (Breast) Experimental Treatment 1 Intervention

Dermaprazole cream at a concentration of 1% will be applied to the skin twice daily starting from CT simulation throughout the radiation treatment period.

Who Is Running the Clinical Trial?

Michelle S Ludwig

Lead Sponsor

Trials

2

Recruited

40+

Published Research Related to This Trial

Five out of seven cancer drugs studied (Adriamycin, Bleomycin, Methotrexate, Mitomycin-C, and Cis-platinum) significantly increased skin reactions when combined with radiation, indicating they enhance the effects of radiation therapy.

Cyclophosphamide showed a protective effect against radiation damage, while 5-fluorouracil had no significant impact, suggesting that the timing and type of chemotherapy can influence the safety and efficacy of radiation treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cancer chemotherapeutic drugs on the radiation-induced skin reactions in mouse feet. von der Maase, H.[2006]

Radiation therapy often leads to significant skin and mucosal toxicities in cancer patients, with effective management strategies including topical agents for dermatitis, oral care for mucositis, and saliva substitutes for xerostomia.

Pharmacologic interventions, such as topical steroids for dermatitis and palifermin for mucositis, are crucial in alleviating these side effects, highlighting the important role of pharmacists in patient care and symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention and management of radiation-induced dermatitis, mucositis, and xerostomia. Radvansky, LJ., Pace, MB., Siddiqui, A.[2019]

Topical esomeprazole, referred to as dermaprazole, has been shown to significantly improve skin healing and appearance in irradiated areas, demonstrating both anti-inflammatory and antifibrotic effects in animal studies.

Dermaprazole works by activating the Nrf2 pathway, which leads to increased expression of protective proteins like heme oxygenase 1, and it effectively downregulates harmful genes associated with inflammation and fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical Esomeprazole Mitigates Radiation-Induced Dermal Inflammation and Fibrosis. Pham, N., Ludwig, MS., Wang, M., et al.[2020]

Metoclopramide enhances the effectiveness of radiation therapy when given one hour before treatment, particularly in human squamous cell carcinomas in mice, suggesting a potential strategy for improving cancer treatment outcomes.

Importantly, metoclopramide does not increase radiation-induced damage to normal tissues, as shown in studies of skin reactions and bone marrow toxicity, indicating its safety for use alongside radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Normal tissue reactions in mice after combined treatment with metoclopramide and ionizing radiation. Lybak, S., Kjellén, E., Nilsson, P., et al.[2019]

In a study of 191 breast cancer patients, three topical agents (Curcumin, HPR Plus™, and a placebo) were tested for their effectiveness in preventing radiation dermatitis, but no significant differences in skin reaction severity were found among the groups overall.

However, in patients with a high breast field separation (≥ 25 cm), curcumin showed potential benefits in reducing skin reactions and pain, suggesting it may be particularly helpful for those at greater risk of severe dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of topical agents for radiation dermatitis and pain: a randomized clinical trial. Ryan Wolf, J., Gewandter, JS., Bautista, J., et al.[2020]

In a study involving 30 patients undergoing breast irradiation, the use of a non-invasive physical plasma (NIPP) device was found to be safe and well-tolerated, with no reported adverse events or unpleasant experiences during treatment.

Patients treated with NIPP experienced less frequent and milder radiation dermatitis compared to those using standard skin care, suggesting that NIPP could be an effective option for preventing and treating this common side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-Invasive Physical Plasma for Preventing Radiation Dermatitis in Breast Cancer: A First-In-Human Feasibility Study. Dejonckheere, CS., Torres-Crigna, A., Layer, JP., et al.[2022]

A case of radiation recall dermatitis (RRD) was successfully treated with an antioxidant ointment (Mapisal(®)), suggesting its potential effectiveness in managing this acute skin toxicity.

The use of Mapisal(®) may not only help treat RRD but also improve high-grade dermatitis caused by radiotherapy, potentially enhancing patients' quality of life and allowing them to complete their cancer treatments as scheduled.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation recall dermatitis after docetaxel chemotherapy. Treatment by antioxidant ointment. Duncker-Rohr, V., Freund, U., Momm, F.[2021]

Up to 95% of patients undergoing radiation therapy experience moderate-to-severe skin reactions known as radiation dermatitis, highlighting the need for effective management strategies.

This literature review provides insights into various topical agents for treating acute radiation dermatitis, detailing their mechanisms of action and offering a treatment algorithm to assist clinicians in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of acute radiation dermatitis: A review of the literature and proposal for treatment algorithm. Rosenthal, A., Israilevich, R., Moy, R.[2019]

In a study of 100 breast cancer patients undergoing radiotherapy, those using specific hydrating creams (betaglucan, sodium hyaluronate, and Vitis vinifera) experienced significantly lower rates of cutaneous toxicity, with 80% showing mild (G0-G1) toxicity.

The study found that the type of topical treatment used was correlated with the level of skin toxicity, suggesting that certain hydrating treatments can effectively reduce the risk of skin damage during radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of cutaneous damages induced by radiotherapy in breast cancer: an institutional experience. Ravo, V., Calvanese, MG., Di Franco, R., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05269160

Topical Dermaprazole for Radiation Dermatitis in 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6876297/

Topical Esomeprazole Mitigates Radiation-Induced Dermal ... Histological data showing that dermaprazole improves skin histology in a radiation dermatitis model. Panel A: H&E stained irradiated skin tissue from ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/31/NCT04865731/Prot_SAP_000.pdf

A Phase II Clinical Trial of Dermaprazole Cream for Radiation ... Our most recent data in a mouse model of RD shows that PPIs have remarkable effect in protecting the skin from the harmful effects of ionizing radiation.

4. withpower.com withpower.com/trial/phase-2-radiodermatitis-3-2022-84518

Topical Dermaprazole for Radiation Skin Damage in Cancer ... This trial tests a cream called Dermaprazole to prevent skin problems in patients receiving radiation therapy for head and neck or breast cancer.

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-04791

Dermaprazole for the Management of Radiation Dermatitis ... This phase I/II trial tests the safety, side effects, best dose, and effectiveness of Dermaprazole for managing radiation dermatitis in patients with head ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04865731

Dermaprazole Cream for Radiation Dermatitis in Head and ... 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 ( ...