Clinical trial · Interventional
Hydrogen Peroxide Trial to Investigate the Efficacy of 30%H2O2 as a Topical Application Before Definitive Treatment
A Phase 2 Double-blind Placebo Randomized Controlled Trial of 30% Topical Application of Hydrogen Peroxide as Neoadjuvant Treatment of Non-melanoma Skin Cancers Prior to Definitive Surgery or Radiation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Previous work suggests that topical treatment with 33% hydrogen peroxide can reduce lesion size and, in about half of patients, can cause complete pathologic response. For patients with reduction in lesions size, the required size of the surgical excision or radiation field will be similarly decreased, thus potentially limiting associated morbidity and better cosmetic outcomes. Additionally, patients that experience a complete pathological response will be able to avoid additional treatment with either surgery or radiation. This will benefit both patients as well as helping to decreased use of health care resources. For the current study we will be using 30% hydrogen peroxide as it is commercially available. If this study shows positive results, it could lead to significant benefit on both a patient and systems level. Locally, our cancer Centre treats approximately 700 new patients per year who fit into the study criteria and could potentially benefit from this novel neoadjuvant treatment that is fairly inexpensive.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Squamous Cell Carcinoma of Skin Differentiated | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydrogen Peroxide 30 % Topical Solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 30% hydrogen peroxide
- description
- 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.
- interventionNames
- Drug: Hydrogen Peroxide 30 % Topical Solution
- type
- PLACEBO_COMPARATOR
- label
- 3% hydrogen peroxide
- description
- 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.
- interventionNames
- Drug: Hydrogen Peroxide 30 % Topical Solution
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed measurable basal cell carcinoma (BCC) or well to moderately differentiated squamous cell carcinoma (SCC) * Age 18 years or older * Able to provide informed consent Exclusion Criteria: * Lesion with indistinct borders * Any evidence of metastatic disease * Poor performance status (Eastern Cooperative Oncology Group \> 1) with life expectancy of less than 2 years * Gorlins syndrome, a genetic predisposition to multiple skin cancers where surveillance and early intervention is of paramount importance * Any recurrent cancer after surgery or radiation * Very extensive carcinoma that cannot be readily removed by surgery or treated by radiation using orthovoltage or electron beam * History of cutaneous photosensitization, porphyria or photodimerization as their tolerance to hydrogen peroxide application is unpredictable * Previous application of 5-Fluorouracil cream to the lesion within the last 8 weeks * Any immune-compromised patients where skin cancers can be very aggressive * Patients who are unwilling to return for 1-year follow-up assessment * Poorly differentiated SCC
References
Publications (0)
Data not yet available