A clinical study comparing methyl aminolevulinate photodynamic therapy and surgery in small superficial basal cell carcinoma (8–20 mm), with a 12-month follow-up
Abstract
OBJECTIVE: To compare the efficacy and cosmetic outcome (CO) of photodynamic therapy with topical methyl aminolevulinate (MAL-PDT) with simple excision surgery for superficial basal cell carcinoma (sBCC) over a 1-year period. METHODS: In this multicentre, randomised, controlled, open study, patients were treated at baseline either with MAL-PDT (two sessions, 7 days apart, repeated 3 months later if incomplete clinical response) or surgery (at baseline). Primary endpoints were clinical lesion response (CR) 3 months after last treatment and CO assessed by the investigator 12 months after last treatment. Secondary endpoints were CR at 12 months (i.e. recurrence) and CO assessed by the investigator at 3 and 6 months and by the patient at 3, 6 and 12 months. RESULTS: Overall, 196 patients were enrolled with 1.4 sBCC lesions on average per patient. Mean lesion count reduction at 3 months was 92.2% with MAL-PDT vs. 99.2% with surgery [per protocol (PP) population] confirming the non-inferiority hypothesis (95% confidence interval, -12.1, -1.9). A total of 92.2% lesions showed CR at 3 months with MAL-PDT vs. 99.2% with surgery (PP population). At 12 months, 9.3% lesions recurred with MAL-PDT and none with surgery. CO was statistically superior for MAL-PDT at all time points. At 12 months, 94.1% lesions treated with MAL-PDT had an excellent or good CO according to the investigator compared with 59.8% with surgery. This difference was confirmed with the patients' assessment. The proportion of excellent CO markedly improved with time with MAL-PDT unlike surgery. CONCLUSIONS: MAL-PDT offers a similarly high efficacy and a much better CO than simple excision surgery in the treatment of sBCC.
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Several studies have shown that PDT results in superior cosmetic outcomes compared to surgical treatment.
“Several studies have shown that PDT results in superior cosmetic outcomes compared to surgical treatment.”
From Photodynamic Therapy for Non-Melanoma Skin Cancers (2016) · cites this paper as [42]
Compared to surgical excision, PDT appears to result in higher BCC recurrence rates.
“Compared to surgical excision, PDT appears to result in higher BCC recurrence rates [42,47,51,52,54].”
From Photodynamic Therapy for Non-Melanoma Skin Cancers (2016) · cites this paper as [42]
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- Authors
- Szeimies, R., Ibbotson, S., Murrell, D., Rubel, D., Frambach, Y., De Berker, D., Dummer, R., Kerrouche, N., Villemagne, H., & on behalf of the Excilight Study Group
- Affiliations
- University Hospital Regensburg (DE)
- Ninewells Hospital (GB)
- Skin and Cancer Foundation (AU)
- University of Lübeck (DE)
- University Hospital Zurich (CH)
- Galderma (France) (FR)
- Corresponding author
- Szeimies, RM
- Venue
- Journal of the European Academy of Dermatology and Venereology
- Publisher
- Wiley
- Published
- 2008-10-10
- Volume
- 22
- Issue
- 11
- Pages
- 1302-1311
- ISSN
- 0926-9959 (ISSN-L)
- 1468-3083
- OpenAlex
- W2167106546
- Cited by
- 247
- References
- 28
- Citations by year
- 2026: 6 · 2025: 12 · 2024: 8 · 2023: 11 · 2022: 12 · 2021: 15 · 2020: 13 · 2019: 19 · 2018: 25 · 2017: 19 · 2016: 17 · 2015: 19 · 2014: 13 · 2013: 16 · 2012: 9
- FWCI
- 7.92
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of the European Academy of Dermatology and Venereology (publishedVersion)
- PubMed (publishedVersion)
- Discovery Research Portal (University of Dundee) (submittedVersion)
- University of Regensburg Publication Server (University of Regensburg) (submittedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Nonmelanoma Skin Cancer Studies
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Photodynamic Therapy Research Studies
- Health Sciences › Medicine › Otorhinolaryngology › Head and Neck Cancer Studies
- Keywords
- superficial basal cell carcinoma, methyl aminolevulinate, photodynamic therapy, surgical excision, cosmetic outcome, recurrence, treatment efficacy, non-inferiority
- MeSH terms
- Administration, Topical, Adult, Aged, Aged, 80 and over, Aminolevulinic Acid, Basal Cell Carcinoma, Combined Modality Therapy, Female, Follow-Up Studies, Humans, Male, Middle Aged, Photochemotherapy, Skin Neoplasms, Treatment Outcome, Photosensitizing Agents
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