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临床试验/NCT02018679
NCT02018679已完成1 期

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

Dong-A University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
34
试验地点
2
主要终点
Difference the efficacy between Er:YAG AFL-PDT and MAL-PDT

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
38 Years 至 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient's request for alternative treatment due to the lower cosmetic outcomes of surgery
  • difficulty to surgical excision due to bleeding abnormalities or cardiac problems

排除标准

  • patients with more than 5 eligible lesions
  • lesions deeper than 2mm in depth
  • lesions located in the midface region, nose, orbital areas, and ears
  • lesions with a longest diameter of less than 6 mm or more than 15mm
  • infiltrative BCC
  • morpheaform BCC
  • known allergies to the MAL cream or lidocaine
  • pregnancy
  • lactation
  • any active systemic infectious disease
  • immunosuppressive treatment
  • personal history of malignant melanoma
  • tendency towards melasma or keloid formation
  • prior treatment of the lesions within 4 weeks
  • any indication of poor compliance

结局指标

主要结局

Difference the efficacy between Er:YAG AFL-PDT and MAL-PDT

时间窗: Efficacy was evaluated at 3 months and 12 months after treatment

Lesion responses were classified as either a complete response (complete disappearance of the lesion) or a non-complete response (incomplete disappearance)

次要结局

  • Difference of the cosmetic outcomes between Er:YAG AFL-PDT and MAL-PDT treatment(Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 3 or 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Song Ki-Hoon

Assistant professor and chairman, Department of dermatology Dong-A University, College of medicine

Dong-A University

研究点 (2)

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