Dermaprazole Cream for Radiation Dermatitis

Overseen By Epp Goodwin

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mohamad Hassan Fakhreddine

Must not be taking: Proton pump inhibitors

Disqualifiers: Prior radiotherapy, Neoadjuvant chemotherapy, Autoimmune disorders, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of Dermaprazole Cream, a new treatment for skin irritation caused by radiation therapy in head and neck cancer patients. Researchers aim to determine if this cream reduces skin problems more effectively than Aquaphor, a common treatment. Individuals with head and neck cancer scheduled for specific radiation treatments may be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

If you are currently taking proton pump inhibitors, you will need to stop them with your doctor's approval to participate in the trial. The protocol does not specify about other medications.

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

Research shows that Dermaprazole Cream is being tested for safety in human use. In earlier studies, participants using a similar cream experienced few side effects. This cream is a new version of a medication typically used for stomach issues. Early tests indicated that these creams are generally safe for skin application.

In trials with patients who have breast cancer or head and neck cancer, Dermaprazole Cream did not cause serious side effects. Most side effects were mild, such as redness or itching, which are common with skin treatments. These findings suggest that Dermaprazole Cream is likely safe for most people to use on their skin. However, ongoing research remains important to confirm these results. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care, which typically involves topical treatments like Aquaphor to soothe the skin, Dermaprazole Cream is unique because it introduces a new active ingredient specifically formulated to address radiation dermatitis. Researchers are excited about Dermaprazole because it may offer enhanced protective properties for the skin, potentially reducing inflammation and accelerating healing more effectively than current options. This novel approach could lead to better skin outcomes for patients undergoing radiation therapy, setting it apart from traditional soothing creams.

What evidence suggests that Dermaprazole Cream might be an effective treatment for radiation dermatitis?

Research shows that Dermaprazole Cream, which participants in this trial may receive, may help treat radiation dermatitis, a common skin problem for cancer patients undergoing radiation therapy. Studies have found that Dermaprazole can improve skin health and appearance in animals with radiation damage. Early results also suggest that the cream reduces skin irritation and redness in people undergoing radiation treatment. Its main ingredient, a modified type of medication typically used for stomach issues, has anti-inflammatory properties that may help calm and protect the skin. While more research is needed, these early findings are promising for those considering this treatment. ^{2 6 7 8 9}

Who Is on the Research Team?

Shraddha Dalwadi, MD

Principal Investigator

The University of Texas Health Science Center - Mays Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with head and neck cancer, excluding brain malignancies, who are set to receive at least 66Gy of chemoradiation. They should have a performance status that allows daily activities (ECOG 0-2) and no prior treatments like head and neck radiotherapy or neoadjuvant chemotherapy. Those taking proton pump inhibitors must stop with their doctor's approval.

Inclusion Criteria

I have a cancer in my head or neck area, but not in my brain.

I am scheduled for a specific cancer treatment with radiation.

I have a confirmed diagnosis of head and neck cancer from a biopsy.

Exclusion Criteria

I have received chemotherapy before surgery.

I do not have any serious health issues that would make the trial treatment unsafe for me.

I have had radiotherapy for head or neck cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Dermaprazole cream or Aquaphor for 7 weeks

7 weeks

Twice daily application

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 months

What Are the Treatments Tested in This Trial?

Interventions

• Dermaprazole Cream

Trial Overview The study tests Dermaprazole cream against Aquaphor in preventing radiation dermatitis during cancer treatment. It aims to see if the reformulated proton pump inhibitor cream is safe and effective for patients undergoing definitive chemoradiation therapy for head and neck cancers.

How Is the Trial Designed?

Group I: Dermaprazole Experimental Treatment 1 Intervention

30 HNC patients who will be using Dermaprazole twice daily for 7 weeks

Group II: Aquaphor Active Control 1 Intervention

15 HNC patients using Aquaphor, the current clinical standard of care

Who Is Running the Clinical Trial?

Mohamad Hassan Fakhreddine

Lead Sponsor

Trials

1

Recruited

6+

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Published Research Related to This Trial

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]

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]

Citations

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

A Phase II Clinical Trial of Dermaprazole Cream for Radiation ... Prevention and treatment of acute radiation-induced skin reactions: a systematic review and meta-analysis of randomized controlled trials. BMC Cancer. R. R. ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT04865731

Dermaprazole Cream for Radiation Dermatitis in Head and ... A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7295106/

Topical treatment of radiation-induced dermatitis This paper reviews the pathophysiology of RID and currently used topical products for the prevention and treatment of RID.

5. 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.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05269160

Topical Dermaprazole for Radiation Dermatitis in Breast ... The aim of this study is to investigate the safety and tolerability (Phase I) and preliminary efficacy (Phase II) of prophylactic esomeprazole cream (termed " ...

7. 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 ( ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1078817421001334

Radiation induced skin reactions during and following ... Skin reactions are a common adverse effect of radiotherapy with approximately 95% of patients experiencing some skin changes during treatment. Most of these ...

9. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00063-9/fulltext

MASCC clinical practice guidelines for the prevention and ... Acute radiation dermatitis (ARD) has long been recognized as a common adverse effect of external beam radiotherapy (RT), developing in up to 95% ...