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临床试验/NCT01459393
NCT01459393已完成3 期

Evaluation of the Formulation of 5-aminolevulinic Acid With Dimethylsulfoxide in Photodynamic Therapy for Treatment of Actinic Keratosis

Barretos Cancer Hospital1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
137
试验地点
1
主要终点
Complete response rates

研究概览

简要总结

This study aims to compare in a prospective and randomized way actinic keratosis treatment with 5-aminolevulinic acid photodynamic therapy versus cryotherapy, from the standpoint of therapeutic efficacy, pain, and cosmetic results.

详细描述

Actinic keratosis is a skin lesion induced by chronic sun exposure with a significant prevalence and malignant potential for squamous cell carcinoma, which makes essential its treatment. Today there are several possible therapies, where cryotherapy is usually applied in our practice. Photodynamic therapy (PDT)is another method also widespread for keratosis which involves the administration of a topical precursor drug which produces endogenous photosensitising substances activated by specific light, selectively destroying the diseased tissue. This study aims to evaluate the use the drug formulation for photodynamic therapy 5-aminolevulinic acid (5-ALA) associated with dimethyl sulfoxide, comparing its efficacy with conventional cryotherapy, and also pain and cosmetic results. This project enrolled 137 outpatients from the Department of Cutaneous Oncology of Barretos Cancer Hospital - Pio XII Foundation, with symmetrical and comparable keratosis in their upper limbs. With the same patient as controls, side arm and therapy to be used were randomized: cryotherapy or photodynamic therapy. For cryotherapy was utilized bottles of liquid nitrogen (Cry-ac, 500ml); and for photodynamic therapy was utilized incoherent red light lamp with a total dosis of 37J/cm² . There was one or two sessions of each therapy , at 0 and 3 months; and three assessments for evaluation were done at 0, 3 and 6 months of onset. The evaluations on efficacy were in terms of area regression, and classified as complete response or no response. Pain was assessed by visual analogue scale, and numerical scale. Cosmesis was evaluated with the presence or not, objectively, of hyper, hypopigmentation or scar retraction. Finally, patient's preference regarding utilized therapeutics was noted by the researcher.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patients older than 18 years.
  • Patients with actinic keratoses "symmetrical", ie, comparable in the upper limbs ( with the same grade, I, II or III).
  • Patients in accordance with informed consent.

排除标准

  • Patients with concomitant skin diseases, congenital or acquired (albinism, vitiligo, xeroderma, Gorlin, etc.)
  • Immunosuppression (HIV, transplanted patients, etc.)
  • Pregnancy or lactation
  • Patients who do not agree with the informed consent initially or during the protocol.
  • Presence of pigmented lesions near the keratoses.
  • Patients with porphyria.
  • Patients who have undergone less than 2 months with some kind of treatment for keratosis in the upper limbs.

研究组 & 干预措施

5-ALA Photodynamic Therapy

Experimental

Topical application of a 2mm of thickness layer of 20% 5-aminolevulinic acid (5-ALA) associated with 20% dimethyl sulfoxide (DMSO) and 3% ethylene diamine acid (EDTA) emulsion, over the actinic keratosis lesion and over a 0,5 cm margin around it. After a 4 hours interval under light protection with plastic film and aluminum foil, the light protection and the emulsion is removed. Then the lesion is lightened with a red (630 nm) incoherent LED lamp AKTILITE CL 128 (PhotoCure ASA, Oslo, Norway) with a total light dose of 37J/cm2.After that dressings are done and kept for 24H, and removed at patient home.

干预措施: 5-ALA Photodynamic Therapy (Drug)

Cryotherapy with liquid nitrogen

Active Comparator

Topical application of liquid nitrogen spray (500ml Cry-ac ® bottle) over the actinic keratosis lesion and over a 0,5 cm margin around it during sufficient time to freeze both the lesion and margin.

干预措施: Cryotherapy with liquid nitrogen (Drug)

结局指标

主要结局

Complete response rates

时间窗: 0 months (baseline), 3 months and 6 months

Clinical evaluation of treated area.

次要结局

  • Visual Analogic Scale Pain Score(0 months (baseline), 3 months, 6 months)
  • Cosmesis analysis(3 months, 6 months)

研究者

发起方
Barretos Cancer Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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