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

6 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new cream called Dermaprazole on patients with head and neck cancer. The cream is a special version of a medicine that usually reduces stomach acid. Researchers want to see if it is safe and effective for these patients.

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.

What data supports the effectiveness of the drug Dermaprazole Cream for treating radiation dermatitis?

Research shows that Dermaprazole Cream, which contains esomeprazole, can reduce skin inflammation and scarring caused by radiation. In studies, it helped improve the appearance of damaged skin and sped up wound healing by reducing inflammation and fibrosis (thickening and scarring of tissue). ^{1 2 3 4 5}

How is Dermaprazole Cream different from other treatments for radiation dermatitis?

Dermaprazole Cream is unique because it uses a topical form of esomeprazole, which is typically an oral medication for acid reflux, to reduce skin inflammation and fibrosis caused by radiation. It works by activating protective pathways in the skin, offering a novel approach compared to traditional treatments that may not effectively address these issues. ^{1 5 6 7 8}

Research Team

Shraddha Dalwadi, MD

Principal Investigator

The University of Texas Health Science Center - Mays Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Topical Esomeprazole Mitigates Radiation-Induced Dermal Inflammation and Fibrosis. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Non-Invasive Physical Plasma for Preventing Radiation Dermatitis in Breast Cancer: A First-In-Human Feasibility Study. [2022]

3. France pubmed.ncbi.nlm.nih.gov

[Treatment and prevention of acute radiation dermatitis]. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Pharmaceutical management of acute radiation dermatitis in the German speaking radiation oncology community. [2023]

5. China pubmed.ncbi.nlm.nih.gov

Role and mechanism of radiological protection cream in treating radiation dermatitis in rats. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Mepitel Film for the Prevention of Acute Radiation Dermatitis in Breast Cancer: A Randomized Multicenter Open-Label Phase III Trial. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Radiation recall dermatitis after docetaxel chemotherapy. Treatment by antioxidant ointment. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

A Feasibility Study of Mepitel Film for the Prevention of Breast Radiation Dermatitis in a Canadian Center. [2021]