EUCTR2017-004608-22-FR进行中（未招募）1 期
Open, prospective, single-center study evaluating the efficacy and safety of 0.05% ingénol mebutate (Picato® 500) in the treatment of basal cell carcinomaStudy PICABAS - Study PICABAS
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- CHU de Nice
- 入组人数
- 28
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
- •Patients of both sexes of more than 18 years old
- •Patients having one or several superficial CBC, or nodulaire, of the trunk or the members (scalp and face excluded), confirmed histologically by biopsy
- •primitive CBC, of main line between 1 and 4 cms
- •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 26
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •CBC of the scalp or the face
- •CBC reoffend, sclérodermiforme, infiltrating, métatypique
- •CBC of diameter > 4cm
- •CBC situated unless 10 cms of another CBC included in the protocol
- •allergic Patient in at the MI or in an excipient of the finished product (example alcohol isopropylique) as indicated on the note of the medicine.
- •Patient treaty by immunosuppresseurs, immunomodulateurs, agents cytotoxiques by systematic way or local corticoids applied to the zone of the CBC, during 4 weeks preceding the visit of selection
- •·• cosmetic or therapeutic Treatment or any procedure which could interfere with the evaluation of the handled zone
- •Presence of a dermatological affection susceptible to interfere with the treatment(processing) or its evaluation (eczema, psoriasis, etc.)
- •Presence of néoplasie associated evolutionary other than a Melanoma of Dubreuil In situ (except squamous-cell carcinoma, carcinoma épidermoïde cutaneous, carcinoma of the in situ neck of the womb and the in situ mammary carcinoma)
- •Use of the MI, the cryotherapy, the imiquimod, Dynamic Phototherapy, or treatment by radiotherapy in the zone of treatment and 5 cms all around in 6 months preceding the first visit
- •pregnant or breast-feeding Woman (an urinary pregnancy test will be realized)
- •Infection known by the HIV
- •transplanted Patient
- •Participation or less than 30 days in a medicinal clinical trial
研究者
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