EUCTR2015-002245-66-AT进行中（未招募）1 期
Impact of light dose on the efficacy of Photodynamic therapy with 5-aminolaevulinic acid (5-ALA) and a 635 +- 9nm emitting LED-lamp for the treatment of actinic keratoses - a randomized, observer-blinded, intraindividual trial - Different light doses ALA-PDT AKs
Medizinische Universität Wien, Univ. Klinik f. Dermatologie0 个研究点开始时间: 2015年11月30日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age >18 years and = 90 years
- •Patients with at least 4-8 actinic keratosis in the face and/or scalp
- •Olsen stage I-II
- •Distance between lesions should be about 1 cm
- •Size of lesions >0,5 and <2,5 cm
- •Skin type I-IV
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Actinic keratoses with Olsen stage> II
- •Photodermatoses like Porphyria cutanea tarda, PLE or Xeroderma pigmentosum
- •Diseases that will be aggravated by light, e.g. lupus erythematodes
- •Porphyria or intake of photosensitizing drugs
- •Known allergy to aminlevulinic acid
- •specific treatment during the last 4 weeks
- •Patients with severe compromised general state
- •Participation in another clinical trial
- •Patients unable to stick to the study protocol
- •Patients not able to give written informed consent
- •Pregnant or lactating women
- •skin type V-VI
- •allergy against peanuts or soya
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