EUCTR2004-001949-15-DE进行中（未招募）不适用
PD P 506 A applied for 0.5, 1, 2 or 4 hours in combination with red light for photodynamic therapy 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）
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 and dated
- •- Caucasian male and female patients
- •- Age > 18 years
- •- Diagnosis of actinic keratosis (AK) which has been proven histologically in the
- •patient’s history with at least three locally separated lesions located on the head
- •(hairless areas) including the face
- •-Selected AK study lesions are mild to moderate (grade I - II):
- •Mild grade (I): Flat, pink maculae or patch on sun-damaged skin,
- •background mottling, no roughness or hyper-keratosis.
- •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 the study (e.g. antineoplastic topical formulations as e.g. Metvix®, Solaraze®, 5-FU or vitamin A acid containing formulations)
- •- Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding the study with keratolytic agents e.g. urea or salicylic acid containing formulations
- •- Treatment with systemic retinoids during the 3 months preceding the study
- •- Use of photosensitising drugs e.g. tetracycline within a time frame where photosensitisation from these drugs may still be present
- •- Female patients of childbearing potential
- •- Diagnosis of Porphyria
- •- Known or suspect acute or chronic hepatic diseases (levels of ASAT, ALAT and/or gamma-GT more than 1.5 times the upper normal limit)
- •- Manifest renal diseases with renal dysfunction
- •- Known suppression of the immune system caused either virally or pharmacologically
- •- Condition after organ transplantation
- •- Any major concomitant disease
- •- Psoriasis on the head
- •- Skin diseases that might interfere with response evaluation of PD P 506 A-PDT
- •- Skin sun sensitivity type V or VI according to Fitzpatrick
- •- Known intolerance to one or more of the ingredients of the study medication
- •- 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
- •- Relationship of dependence between patient and sponsor or patient and investigator
研究者
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