Microinvasive Squamous Cell Carcinoma Clinical Trial
Official title:
A Randomised Trial Comparing Methyl Aminolaevulinate Photodynamic Therapy With and Without Ablative Fractional Laser Treatment in Patients With Microinvasive Squamous Cell Carcinoma: Results From a 24-month Follow-up
Surgical excision is the standard treatment for cutaneous SCC. However, many patients diagnosed with SCC are elderly and ineligible for surgery. Ablative fractional laser- assisted photodynamic therapy (AFL-PDT) offered a higher efficacy than conventional Methylaminolevulinate (MAL)-PDT.
Squamous cell carcinoma (SCC) lesions are potentially metastatic and can be life
threatening. Hence, surgical excision is the standard treatment for cutaneous SCC. However,
some patients are ineligible for surgery because of their poor general health, concomitant
anticoagulant or immunosuppressive therapies, or allergy to local anesthetics.
Photodynamic therapy (PDT) with methylaminolevulinate (MAL) is an innovative treatment
modality that has been approved in Europe for the treatment of actinic keratosis, basal cell
carcinoma, and Bowen's disease. However, currently, there is insufficient evidence to
support the routine use of topical PDT for SCC.
Ablative fractional laser (AFL) ablates the epidermis and dermis without significant thermal
injury, creating microscopic ablation zones in the portion of the skin that the laser is
applied to. Our previous studies showed that AFL-primed MAL-PDT (AFL-PDT) offered a higher
efficacy than conventional MAL-PDT in the treatment of many other diseases, such as actinic
keratosis, actinic cheilitis, and Bowen's disease.
Investigators recruited Korean patients with microinvasive SCC and compared the efficacy,
recurrence rate, and cosmetic outcomes of AFL-PDT with those of standard MAL-PDT.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment