EUCTR2012-002845-40-DE进行中（未招募）不适用
Bi-center, open label, non-comparative trial exploring efficacy and safety of topical resiquimod gel (0.06%) in patients with nodular basal cell carcinoma (nBCC).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •Signed consent form.
- •Male or non-pregnant, non-lactating female, = 18 years. For women of childbearing potential the use of highly effective methods of birth control (precautions to prevent pregnancy) is mandatory. Highly effective methods of birth control are defined as those, alone or in combination, which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly – such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. In this trial women of childbearing potential are instructed to use oral contraceptives or IUDs in combination with a barrier device (e.g. condom).
- •Must have a previously untreated, histologically confirmed nBCC on head, neck, trunk or arms.
- •nBCC must not be larger than 20 mm in diameter and must be less than 5 mm in depth.
- •Willing and able to participate in the trial as an outpatient and comply with all trial requirements.
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •nBCC located close to or at mouth or eyes.
- •Patients who have had an organ transplant.
- •Known autoimmune disorder (especially psoriasis), impaired immune system (e.g. HIV), known thyroid abnormalities, known depression.
- •An open wound or an infection in treatment area.
- •Dermatological disease or condition (e.g. rosacea, atopic dermatitis, eczema) in the treatment or surrounding area that might impair trial assessments.
- •Evidence of an active infection or systemic cancer.
- •Flu or flu-like symptoms (including general indisposition, fever, nausea, muscle pain, chills) within a week before start of the trial.
- •Known allergy or hypersensitivity to any of the trial gel ingredients.
- •Evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., renal or hepatic disease).
- •Current alcohol abuse or chemical dependency as assessed by the investigator.
- •Patient who is detained or committed to an institution by a law court or by legal authorities.
- •Participation in another clinical trial within one month before start of the trial.
- •Treatments before the start of the trial (restrictions):
- •Local/topical treatments in the treatment area:
- •Photodynamic treatment or 5-Fluorouracil (5-FU) within 2 weeks of the start of the trial.
- •Laser treatment, cryotherapy or surgical treatment within 4 weeks of trial entry.
- •Imiquimod, topical corticosteroids or topical retinoids within 8 weeks of trial entry.
- •Systemic treatments:
- •High-dose vitamin A (> 15’000 units per day) within 2 weeks of trial entry.
- •Immunomodulatory or cytotoxic treatments, systemic (> 10 mg/day) or high-dosed inhaled (> 1600 ?g/day) corticosteroids within 4 weeks of trial entry.
- •Interferon/interferon-inducers or immunosuppressors within 8 weeks of trial entry
- •Chemotherapy, radiation therapy or systemic retinoids, treatment with UVB or psoralens with UVA within 6 months of trial entry.
研究者
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