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Published on: November 28, 2011
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Calcium Electroporation for Keloids: A First-in-Man Phase I Study
Hanne Falk1, Mille Vissing2,3, Gitte Wooler4
1Department of Oncology, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.
Summary
Calcium electroporation (CEP) is a safe and effective treatment for keloids, reducing pain and pruritus. This phase I study showed promising results in keloid thickness reduction and symptom relief with minimal side effects.
Area of Science:
- Dermatology
- Oncology
- Medical Technology
Background:
- Keloid scarring is a challenging condition characterized by excessive scar tissue growth, often leading to discomfort and disfigurement.
- Current keloid treatments have limitations, including high recurrence rates and potential side effects.
- Calcium electroporation (CEP) has shown promise in treating other skin conditions and was investigated for keloids due to its favorable safety profile.
Purpose of the Study:
- To evaluate the safety and efficacy of intralesional calcium combined with electroporation (calcium electroporation) for the treatment of keloid scarring.
- To assess the impact of calcium electroporation on keloid size, shape, erythema, pain, and pruritus.
- To conduct a phase I clinical study to establish preliminary data on calcium electroporation for keloid treatment.
Main Methods:
- Six patients with keloids received at least one session of calcium electroporation.
- Treatment involved intralesional calcium administration (220 mM) followed by electroporation pulses (eight 100-µs pulses at 400 V) using specific electrodes.
- Efficacy was assessed through clinical evaluation, patient-reported outcomes (pain, pruritus), and histological analysis over a 2-year follow-up period.
Main Results:
- Calcium electroporation was well-tolerated, with all patients desiring further treatment.
- Two out of six patients experienced over a 30% decrease in keloid thickness.
- A mean reduction in volume size (11%) and flattening (22%) was observed, alongside significant symptom relief (decreased pain and pruritus in 5/6 patients).
Conclusions:
- Calcium electroporation is a safe treatment for keloids with minor side effects.
- The study demonstrated potential for keloid thickness reduction and significant improvement in patient-reported symptoms.
- This phase I study provides a foundation for further investigation into calcium electroporation as a viable keloid treatment option.

