Study of Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Laser in Actinic Cheilitis
Condition: Actinic Cheilitis
MeSH terms: Cheilitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is advantageous in that it has few
      cosmetic side effects and minimises patient discomfort. However, its relatively low efficacy
      prevents its application to the treatment of actinic cheilitis(AC). Er:YAG ablative
      fractional laser (AFL) treatment removes the stratum corneum to increase MAL uptake and may
      improve efficacy. However, no studies have directly compared the efficacy of MAL-PDT with and
      without Er:YAG AFL in treating AC
    

Detailed description: 
      Actinic cheilitis (AC) is a keratinocytic neoplasm of the lip, especially the lower lip, is
      confined to the epidermis, and results from chronic or excessive ultraviolet exposure. AC is
      an early manifestation of lip squamous cell carcinoma (SCC), and SCC of the lip is usually
      associated with an identifiable pre-existent AC. Furthermore, the likelihood that AC will
      progress to SCC is higher than actinic keratosis (AK). Consequently, early identification and
      treatment of AC is recommended. PDT involves the activation of a photosensitizer by
      irradiation with 400- to 700-nm light to create cytotoxic oxygen and free radicals that kill
      dysplastic cells.

      Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is advantageous in that it has few
      cosmetic side effects and minimises patient discomfort. However, its relatively low efficacy
      prevents its application to the treatment of actinic cheilitis(AC).

      Erbium:yttrium-aluminium-garnet (Er:YAG) ablative fractional laser (AFL) therapy has been
      used frequently to improve treatment efficacy of PDT. Er:YAG AFL can ablate stratum corneum
      with minimal penetration depth and producing minimal thermal injury. This approach creates
      microscopic vertical holes in the ablated tissue, surrounded by thin layers of coagulated
      tissue. Er:YAG AFL does not injure the entire thickness of the epidermis; therefore, healing
      times are minimised. Erbium:yttrium-aluminium-garnet (Er:YAG) ablative fractional laser (AFL)
      has been proven in recent studies to facilitate the delivery and uptake of topical MAL deep
      into the skin, enhancing porphyrin synthesis and photodynamic activation.

      The aim of our study was to compare efficacy, recurrence rate, cosmetic outcome, and safety
      between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL MAL-PDT) and standard MAL-PDT in patients
      with AC.
    

Intervention name(s): Er:YAG AFL-PDT; MAL-PDT
Intervention type(s): Drug; Drug
Intervention description(s): Er:YAG AFL was performed with 350 µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse. MAL cream was then applied under occlusion for 3 hrs and illuminated with a red light-emitting diode light at 37 J/cm2.; a 1-mm thick layer of MAL (16% Metvix® cream, PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm, 3M, Saint Paul, MN, US) for 3 hours, 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 with red light-emitting diode (LED) lamps (Aktilite CL128; Galderma, Bruchsal, Germany) with peak emission at 632 nm and total light dose of 37 J cm-2. Areas scheduled to receive MAL-PDT received the second treatment 7 days later.
Other intervention name(s): Er:YAG ablative fractional laser-assisted MAL-PDT; methyl aminolaevulinate-Photodynamic therapy
Intervention MeSH terms: Methyl 5-aminolevulinate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: actinic cheilitis; Er:YAG ablative fractional laser; methyl aminolevulinate photodynamic therapy