EUCTR2013-005546-11-IT进行中（未招募）不适用
Characterisation of maximum actinic keratosis (AK) lesions count during treatment (Lmax) by non-invasive study with high definition optical coherence tomography (HD-OCT) and reflectance confocal microscopy (RCM)
DEPARTMENT OF DERMATOLOGY, UNIVERSITY OF MODENA AND REGGIO EMILIA0 个研究点开始时间: 2014年4月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •To be eligible, a patient must comply with all of the following criteria:
- •1.Immunocompetent Caucasian patient.
- •2.5-20 clinically evident AK lesions either on full face or balding scalp.
- •female without child-bearing potential.
- •4.Having at least 1 AK and 1 subclinical lesion in the study area diagnosed by HD-OCT or RCM.
- •5.Willingness to have reflectance confocal microscopy examination and HD-OCT examination performed in treatment area.
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •A patient is ineligible and must not enter the study if any of the following criteria is met:
- •Safety concerns:
- •1.Contraindications for Imiquimod treatment: Hypersensitivity to Imiquimod or to any of the excipients (isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), xanthan gum).
- •2.Broken skin in the study treatment area.
- •3.Autoimmune condition.
- •4.Severe haematological disease.
- •Lack of suitability for the study:
- •5.Presence of AK lesions in the STA with clinically excessive hyperkeratosis as seen in cutaneous horns.
- •6.Treatment of AKs in region of eyes, lips or nostrils
- •7.Any kind of AK treatment at the STA within the last 2 months prior to randomisation.
- •8.Presence of any histologically confirmed skin tumour in the STA: in situ SCC including Bowen’s disease, invasive SCC, basal cell carcinoma, or other malignant tumours.
- •9.Systemic immunomodulatory treatment such as interferon, azathioprine, cyclosporine, retinoids, any oral or injectable corticosteroids, or inhaled or nasal corticosteroids with dosages of >1200 µg/day beclomethasone or equivalent within 4 weeks before start of study treatment.
- •10.History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years which might hinder regular treatment and supervision and might lead to premature withdrawal from the study.
- •11.Mentally incapacitated patient.
- •12.Present or history of drug or alcohol abuse within the last 3 years.
- •Administrative reasons:
- •13.Exposure to an investigational product within the last 3 months.
- •14.Lack of ability or willingness to give informed consent.
- •15.Age below 18 years.
- •16.Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.
- •17.Anticipated non-availability for study visits/procedures.
- •18.Vulnerable subjects (such as persons kept in detention)
- •19.The planned sample size has been reached.
研究者
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