Hydrogen Peroxide for Skin Cancer

Overseen By Robin Sachdeva, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Must not be taking: 5-Fluorouracil

Disqualifiers: Metastatic disease, Gorlins syndrome, others

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

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

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a topical treatment using 30% hydrogen peroxide to determine its effectiveness in shrinking or eliminating skin cancer lesions, specifically basal cell carcinoma (BCC) or well to moderately differentiated squamous cell carcinoma (SCC). The goal is to find a less invasive option that could reduce the need for surgery or radiation and offer better cosmetic results. Participants will receive either the 30% hydrogen peroxide or a 3% solution, applied weekly for four weeks. Ideal candidates have confirmed BCC or SCC lesions with clear borders and can provide informed consent. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in skin cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have used 5-Fluorouracil cream on the lesion in the last 8 weeks, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using hydrogen peroxide on the skin is generally safe at low concentrations, between 1% and 6%. However, higher concentrations, such as 9% to 45%, can cause serious skin damage. In past studies with 33% hydrogen peroxide, many patients experienced a noticeable reduction in lesion size, and about half achieved complete healing. This suggests the treatment might be effective, but it also highlights the need to monitor for skin damage. Participants in those studies did not report any unexpected side effects beyond what is typical with high concentrations of hydrogen peroxide. Since this trial is in Phase 2, there is some early evidence of safety, but more information is needed for certainty. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for skin cancer, which often involve surgery, radiation, or chemotherapy, 30% hydrogen peroxide offers a non-invasive topical solution. This treatment is unique because it uses a simple chemical compound, hydrogen peroxide, which is commonly known for its disinfectant properties, to target cancerous lesions directly. Researchers are excited about this approach because it offers a potentially less painful and more convenient option for patients, with treatment administered just once a week for four weeks. If successful, this could represent a significant shift towards more accessible and patient-friendly skin cancer therapies.

What evidence suggests that hydrogen peroxide might be an effective treatment for skin cancer?

Research has shown that applying hydrogen peroxide to the skin can significantly reduce skin cancer spots. In about half of the patients, it can even eliminate the cancer entirely. This treatment breaks down cancer cells, potentially reducing the need for extensive surgery or radiation and improving cosmetic outcomes. One study found that many cancer spots decreased in size after hydrogen peroxide application, facilitating further treatment. In this trial, participants will receive either a 30% hydrogen peroxide topical solution or a 3% hydrogen peroxide solution as a placebo comparator, with the 30% solution expected to provide similar benefits. ^{2 3 4 5 6}

Who Is on the Research Team?

Jinka Sathya, MD

Principal Investigator

Western University

Are You a Good Fit for This Trial?

Inclusion Criteria

Pathologically confirmed measurable basal cell carcinoma (BCC) or well to moderately differentiated squamous cell carcinoma (SCC)

Able to provide informed consent

Exclusion Criteria

You have had a skin reaction to light in the past, or have a medical condition that makes your skin sensitive to hydrogen peroxide.

Previous application of 5-Fluorouracil cream to the lesion within the last 8 weeks

The area being studied has unclear or blurry boundaries.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topical application of 30% hydrogen peroxide once every week for 4 weeks

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Long-term Follow-up

Participants are monitored for long-term outcomes and adverse events

1 year

Visits at 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Hydrogen Peroxide 30 % Topical Solution

How Is the Trial Designed?

Group I: 30% hydrogen peroxide Experimental Treatment 1 Intervention

30% hydrogen peroxide liquid topical application. 2 drops (0.10 ml) of hydrogen peroxide solution per centimeter of lesion. Once every week for continuous 4 weeks. If there is complete clinical response, further hydrogen peroxide will not be done.

Group II: 3% hydrogen peroxide Placebo Group 1 Intervention

3% hydrogen peroxide liquid topical application. 2 drops (0.10 ml) of hydrogen peroxide solution per centimeter of lesion. Once every week for continuous 4 weeks. If there is complete clinical response, further hydrogen peroxide will not be done.

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

Jinka Sathya

Lead Sponsor

Trials

1

Recruited

50+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04929535

Hydrogen Peroxide Trial to Investigate the Efficacy of 30% ... Previous work suggests that topical treatment with 33% hydrogen peroxide can reduce lesion size and, in about half of patients, can cause complete ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7268291/

33% hydrogen peroxide as a Neoadjuvant treatment in the ... We have demonstrated a significant reduction in the size of multiple lesions after application of 33% hydrogen peroxide, simplifying definitive ...

3. withpower.com withpower.com/trial/phase-3-carcinoma-basal-cell-8-2021-ecb3f

Hydrogen Peroxide for Skin Cancer · Info for Participants The hydrogen peroxide works by breaking down cancer cells, potentially leading to smaller treatment areas and better cosmetic outcomes. Hydrogen peroxide has ...

4. ctv.veeva.com ctv.veeva.com/study/hydrogen-peroxide-trial-to-investigate-the-efficacy-of-30-h2o2-as-a-topical-application-before-defin

Hydrogen Peroxide Trial to Investigate the Efficacy of 30 ... Previous work suggests that topical treatment with 33% hydrogen peroxide can reduce lesion size and, in about half of patients, ...

5. ascopost.com ascopost.com/issues/october-25-2020/small-case-study-explores-novel-approach-to-neoadjuvant-therapy-for-skin-cancer/

Small Case Study Explores Novel Approach to ... We did notice a significant reduction in both the length and width of the skin lesions after a single treatment with hydrogen peroxide, and, in ...

6. ijdvl.com ijdvl.com/hydrogen-peroxide-in-dermatology/

Hydrogen peroxide in dermatology A statistically significant decrease in the size of skin malignancies such as squamous and basal cell carcinoma was observed with a single application of the ...