EUCTR2013-001753-26-FR进行中(未招募)1 期
Clinical and biophysics evaluation of the cutaneous modifications following the local use of a lotion containing 0,1 % of trétinoïne.
Pierre Fabre Dermo-cosmétique0 个研究点目标入组 24 人开始时间: 2015年9月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 24
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
- Male
入选标准
- •Relative to the population:
- •O male Adult.
- •O Age included between 18 and 30 inclusive years.
- •O Phototype I to IV
- •o Pilosity reduced at the level of the top of the back
- •o Subject affiliated to a French national insurance scheme,
- •o Subject having given its written consent to its participation in the study.
- •O Registration in the national file of the persons who lend themselves to biomedical researches.
- •Relative to the pathology:
- •Subject having a moderated acne at the level of the back, the evaluation by the investigator global assessment of the acne (rank 1, 2, 3)
- •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 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Relative to the pathologies:
- •· Any dermatological pathology on the back, other than the acne.
- •· Existence of a chronic affection or an evolutionary acute pathology which can interfere with the study.
- •Relative to treatments:
- •· Use of a self-tanning, keratolytic or exfoliating product on the back in 2 weeks preceding the inclusion.
- •· Use on the back of any product which can interfere with the study (produced moisturizer, care product) in 2 weeks preceding the inclusion.
- •· Treatment by oral route by antibiotics in 2 weeks preceding the inclusion.
- •· Treatment by oral route by anti-inflammatory or corticoid during more than 2 consecutive days in 2 weeks preceding the inclusion.
- •- Treatment by local use on the study zone : by anti-inflammatory, corticoid or antibiotics during more than 2 consecutive days in 2 weeks preceding the inclusion.
- •· Hormonal treatment (in thyroid, anti-acned) by oral route in two months preceding the inclusion.
- •· Any anti-acned treatment:
- •O By local use on the study zone (acid azélaique, peroxide of benzoyle, antibiotics, rétinoïdes) in the month preceding the beginning of the study,
- •o By oral use: antibiotics (tétracyclines or macrolides) or zinc in the month preceding the beginning of the study,
- •o By oral use: rétinoïdes in 6 months preceding the beginning of the study.
- •· Allergy or for intolerance in one of the components of the LOCACID lotion ®.
- •· Histories known for allergy or intolerance to the latex.
- •Relative to the population:
- •· Exposure the back to the sun planned during the study.
- •· Presence on the experimental zone of solar erythema or other mark which can interfere with the evaluation of the cutaneous reactions (pigmentation disorders, tattoo).
- •· Participation in a clinical trial on the back in the week preceding the inclusion.
- •· Subject in the impossibility to conform to theprotocol requirements.
- •· Subject having perceived, within the framework of clinical trials, compensations superior to 4 500 euros, this included study, during the last 12 months.
- •· Subject in incapacity to understand the information (for linguistic or psychiatric causes) and to give its consent.
- •Subject confiscated his liberty by administrative or legal decision or guardianship.
- •· Subject which participates at present or which participated in another clinical trial and being in period of exclusion during which he can not participate to another clinical trial.
研究者
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