EUCTR2006-004524-36-FR进行中（未招募）1 期
A randomized, double-blind, vehicle controlled, single center, intra-individual comparative study of the efficacy and safety of diclofenac sodium 1 mg/g (0.1%) gel in subjects with painful UV-induced erythema - Diclofenac sodium 1 mg/g (0.1%) gel
ovartis Consumer Health SA0 个研究点目标入组 0 人开始时间: 2006年10月25日最近更新:
试验速览
- 阶段
- 1 期
- 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
- •Subjects to be included in this trial must:
- •- Sign the written informed consent form prior to the enrolment in the trial;
- •- Be in good health, with no abnormal findings in their medical history or on physical examination;
- •- Be aged 18 to 55 years;
- •- Be a male or non-pregnant, non-lactating female. Women of child-bearing potential have to use acceptable methods of contraception which are surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) and sterilized partners by vasectomy or other means. Total abstinence may be considered as acceptable at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the subject ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study. Women, of non childbearing potential have to meet the following definition of post-menopausal status: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy.
- •- If female, have a negative urine pregnancy test prior to inclusion;
- •- Be covered by the French Social Security system (in agreement with the French legislation: Huriet law n° 88.1138 – 20.12.1988);
- •- Have no dermatologic disorder which could interfere with the study results or increase the risk of adverse events;
- •- Have no skin type providing a skin pigmentation which will not allow discernment of erythema;
- •- Have non tanned skin on the areas to be exposed (back);
- •- Have a phototype II to III (Fitzpatrick’s classification);
- •- Have a normal tolerance to UV and sun.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects to be excluded are those:
- •- Who, if female, is pregnant, planning pregnancy or lactating;
- •- With a known hypersensitivity to diclofenac, aspirin, ibuprofen or other NSAIDs;
- •- Who have used oral or percutaneous therapy during the month preceding the trial, which may interfere with the results of the trial (e.g. corticosteroids, anti-histamines, NSAIDs, any photo-protecting agents or photo-sensitising drugs etc.);
- •- Who received any drug (including any OTC medication) during the week preceding the trial;
- •- Suffering from cutaneous diseases such as psoriasis or active atopic dermatitis, even in sites separated from experimental areas;
- •- Who are prone to photodermatoses or subject with previous occurrence of photoallergy;
- •- Who are immunosuppressed (acquired, congenital or therapeutic);
- •- Suffering from any acute or chronic systemic disease or disorder;
- •- Involved in any investigational protocol within 3 months prior to the trial;
- •- With evidence or history of drug or alcohol abuse;
- •- Who are in the exclusion period in the”Fichier National des Volontaires” of the French Ministry of Health;
- •- Who is a member or relative of the trial site staff or an employee of the trial site or Sponsor.
研究者
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