Efficacy of AFL-assisted PDT in Microinvasive Squamous Cell Carcinoma
Condition: Microinvasive Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): lidocaine-prilocaine 5% cream application; 2940-nm Er:YAG AFL pretreatment; methyl-aminolevulinate application; Illuminating using red light-emitting diode lamps
Intervention type(s): Drug; Device; Drug; Device
Intervention description(s): The lesions were then cleansed with saline gauze, and a lidocaine-prilocaine 5% cream (EMLA®; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area for 30 min under occlusion; After the anesthetic cream was removed, AFL was performed using a 2940-nm Er:YAG AFL (Joule; Sciton, Inc., Palo Alto, CA, USA) with a 500 µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse; Immediately after the AFL, a 1-mm thick layer of methyl-aminolevulinate (16% Metvix® cream; PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of the surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm; 3M, Co., Saint Paul, MN, USA) for 3 h, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light.; Each treatment area was then separately illuminated using red light-emitting diode lamps (Aktilite CL128; Galderma S.A., Bruchsal, Germany) with peak emission at 632 nm and a total light dose of 37 J/cm2. Areas scheduled to receive MAL-PDT received the second treatment 7 days later. During the illumination, patients were asked to evaluate pain intensity using an 11-point visual analog scale.
Intervention MeSH terms: Lidocaine; Prilocaine; Lidocaine, Prilocaine Drug Combination; Aminolevulinic Acid; Methyl 5-aminolevulinate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ablative fractional laser; microinvasive squamous cell carcinoma; photodynamic therapy