NCT00967070已完成1 期
Study on the Skin Sensitization Potential of a New Nicotine Transdermal Therapeutic System (TTS). A Double Blind, Randomized, Repeat Patch Test, Single Center Phase I Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- McNeil AB
- 入组人数
- 257
- 试验地点
- 1
- 主要终点
- Cumulative Individual Irritation Scores
研究概览
简要总结
An investigation on the skin sensitization potential of a new nicotine patch. Evaluation of the potential of a new nicotine transdermal patch to cause sensitization in the skin after repeated applications.
详细描述
Study on the skin sensitization potential of a new nicotine transdermal therapeutic system (TTS). A double blind, randomized, repeat patch test, single center phase I study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male and female subjects between 18 and 65 years
- •Heavy smokers (more than 10 cigarettes per day)
- •Having had no febrile or infectious illness for at least seven days prior to the first administration of the investigational product.
- •Women practicing one or a combination of the following methods of birth control: hormonal contraceptives, condoms, sponge, foams, jelly, diaphragm, or intrauterine device or women who are surgically sterilized.
- •Subjects having normal skin without excessive hair growth on tested areas.
- •Evidence of a personally signed and dated informed consent document indicating that the subjects has been informed of all pertinent aspects of the trial.
- •Subjects who are willing to comply with scheduled visits, treatment plan and other trial procedures.
排除标准
- •Any visible skin disorder or abnormal skin pigmentation which, in the opinion of the investigator, would interfere with the outcome of the trial
- •Dermatologic disease that might interfere with the evaluation of the test site reaction
- •History of chronic, dermatological, medical, or physical conditions which would, in the opinion of the investigator, preclude topical application of the test products and/or influence the outcome of the test (in particular, any immunosuppressive condition)
- •Clinically relevant abnormal findings on the physical examination
- •A baseline score in skin reaction assessments other than "0" on the areas to be patched
- •Pregnant (verified by beta-hCG-test in urine) and/or nursing women
- •Demonstrating any active physical disease, acute or chronic
- •Any suspicion, history or evidence of alcohol or drug abuse
- •Any history of drug hypersensitivity, asthma, urticaria or other severe allergic diathesis as well as current hay fever
- •Any current or past history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological, immunological, psychiatric or cardiovascular disease, myopathies, epileptic seizures and bleeding tendency.
- •Recent myocardial infarct (within the last 3 months), unstable or deteriorating angina pectoris, coronary artery vasospasm (Prinzmetal's angina), serious cardiac arrythmias and acute stroke [added according to Amendment No. 1].
- •Use of any medication within 4 weeks prior to the first treatment or during the trial which, in the opinion of the investigator, may influence the trial results or the safety of the subjects.
- •Use of systemic or topical analgesics or antihistamines within 72 hours prior to trial enrollment (except paracetamol) or systemic or topical corticosteroids within 3 weeks of trial enrollment.
- •Subjects having used nicotine products other than cigarettes within the 3 months preceding the trial
- •Subjects who cannot avoid, throughout the duration of the trial, any swimming, any washing of the back and sauna or any intense physical activity that might result in excessive sweating
- •Known sensitivity to adhesive tape
- •Known sensitivity to any component of the test products
- •History of irritation to topically applied products
- •Fissure or injury of the skin at the test area
- •Participation in the treatment phase of a clinical trial within 30 days prior to the treatment phase of this trial or within 10 times the respective elimination half-life of the investigational drug
研究组 & 干预措施
Both Treatments Applied on Lower Back
Experimental
Treatments were applied on the assigned marked sites on the lower back. Induction phase (21 days): left side, six treatment applications for 48 or 72 h. Challenge phase (five days): right side, one treatment application for 48 h.
干预措施: Nicotine Patch (Drug)
Both Treatments Applied on Lower Back
Experimental
Treatments were applied on the assigned marked sites on the lower back. Induction phase (21 days): left side, six treatment applications for 48 or 72 h. Challenge phase (five days): right side, one treatment application for 48 h.
干预措施: Placebo Patch (Drug)
结局指标
主要结局
Cumulative Individual Irritation Scores
时间窗: 15 or 30 min, and 24, 48, and 72 hr post-application, depending on trial phase
次要结局
- Individual Irritation Score (IIS)(15 or 30 min, and 24, 48, and 72 hr post-application, depending on trial phase)
- Patch adhesion score(directly before patch removal)
- Tolerability(at each visit)
研究者
研究点 (1)
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