Nodular Basal Cell Carcinoma Clinical Trial
Official title:
Er:YAG Ablative Fractional Laser Assisted-Photodynamic Therapy Versus Photodynamic Therapy for Nodular Basal Cell Carcinoma in Asian: A Prospective, Randomized Study With 12 Months Follow-up
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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