EUCTR2005-003556-36-DE进行中（未招募）不适用
Photodynamic Therapy with PD P 506 A or its placebo compared with cryosurgery for the treatment of mild to moderate actinic keratosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 315
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
- •- Written informed consent has been signed prior to or at Screening Visit
- •- Caucasian male and female patients
- •- Age > 18 years
- •- Diagnosis of actinic keratosis (AK) with at least four locally separated lesions located on the head (hairless areas)
- •- Selected AK study lesions have clearly defined margins and are mild to moderate (grades I or II):
- •Mild grade (I): Flat, pink maculae or patch on sun-damaged skin, background mottling, no roughness or hyperkeratosis.
- •Moderate grade (II): Pink to red papule or plaque with rough, hyperkeratotic surface, variable induration.
- •- The distance between the study lesion borders is > 1.0 cm
- •- Maximum diameter of each study lesion is 1.8 cm
- •- Skin sun sensitivity type I to IV according to Fitzpatrick
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- PDT Non-responder
- •- Pre-treatment of the AK lesions eligible for study procedures with pharmaceuticals approved for the treatment of AK during the 4 weeks preceding study treatment (e.g. antineoplastic topical formulations as e.g. Metvix®, Solaraze®, Aldara®, 5-FU or vitamin A acid containing formulations)
- •- Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding study treatment with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations
- •- Pre-treatment with hypericin during the 2 weeks preceding study therapy
- •- Treatment with systemic retinoids during the 3 months preceding study therapy
- •- Treatment with cytostatics or radiation during the 3 months preceding study therapy
- •- Female patients of childbearing potential
- •- Patients with clinically relevant suppression of the immune system
- •- Diagnosis of Porphyria
- •- Skin diseases that might interfere with response evaluation of study treatment
- •- Skin sun sensitivity type V or VI according to Fitzpatrick
- •- Known intolerance to one or more of the ingredients of PD P 506 A or PD P 506 P
- •- Known adverse reactions to cryosurgery (including cold urticaria and cold intolerance)
- •- Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
- •- Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion
- •- Suspected lack of compliance
研究者
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