Er:YAG Ablative Fractional Laser Assisted-Photodynamic Therapy Versus Photodynamic Therapy for Basal Cell Carcinoma
Condition: Nodular Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      Topical photodynamic therapy with methyl-aminolaevulinate (MAL-PDT) has been introduced as an
      alternatively attractive procedure for BCC. 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 Er:YAG AFL-PDT and MAL-PDT in treating nodular
      BCC in Asians.
    

Detailed description: 
      Basal cell carcinoma (BCC) is the most common cancer in the Caucasian population, with an
      incidence rising worldwide. there is an increasing trend in the incidence rates of BCC in
      asian and greater percentage of pigmented BCCs is found to be the most characteristic
      clinical feature of BCC in Asian compared to BCC in Caucasians. Topical photodynamic therapy
      with methyl-aminolaevulinate (MAL-PDT) has been introduced as an alternatively attractive
      procedure for BCC. PDT facilitates the light activation of a photosensitizer in the presence
      of oxygen. The oxygen generates reactive oxygen species leading to selective and highly
      localized destruction of abnormal cells. MAL is an efficient photosensitizer as a result of
      improved lesion penetration attributed to enhanced lipophilicity, decreased charge and also
      has a greater specificity for neoplastic cells, compared with 5-aminolevulinic acid. Because
      histologic features of nBCC include down-growth of epithelial buds into the dermis,
      palisading basal cell and separation of epidermis from the underlying dermis, it is generally
      treated twice within an interval of 1 week.But, MAL-PDT shows the lower efficacy for the
      treatment of pigmented BCC because melanin disturbs the absorption of the MAL. Also, a
      significantly higher proportions of BCC in the Asian population were pigmented BCC compared
      with pigmented BCC of Caucasian. Consequently, additional techniques are needed to enhance
      the penetration and accumulation of MAL in order to improve PDT efficacy and decrease
      treatment duration in darker-skinned patients.

      Er:YAG ablative fractional laser therapy (AFL) can ablate the epidermis and dermis without
      significant thermal injury. This approach creates microscopic ablation zones (MAZ) in
      laser-applied portion of the skin. The tissue with MAZ is surrounded by thin layers of
      coagulated tissue. Since the Er:YAG AFL resurfaces 5-20% of the skin at one time and does not
      injure the entire thickness of the epidermis, healing times are minimized. Recent studies
      have demonstrated that Er:YAG AFL facilitates delivery and uptake of topical MAL deep into
      the skin, enhancing porphyrin synthesis and photodynamic activation. We have compared the
      efficacy, recurrence rate, cosmetic outcomes and safety of Er:YAG AFL-PDT with standard
      MAL-PDT in the treatment of nBCC among Korean populations.
    

Intervention name(s): Er:YAG AFL-PDT; MAL-PDT
Intervention type(s): Procedure; Procedure
Intervention description(s): AFL was performed using a 2940-nm Er:YAG ablative fractional laser (Joule, Sciton Inc., CA, UA) at 550-600 µm ablation in depth, level 1 coagulation, 22% treatment density, and a single pulse. Immediately afterwards, 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 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 cm2. Areas which were scheduled to receive MAL-PDT received the second treatment 7 days later.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nodular basal cell carcinoma; Er:YAG; AFL-assisted; MAL-PDT