Assessment of the activity of a new cream containing betamethasone dipropionate at 0.010%, 0.025% and 0.050% versus reference products using a vasoconstriction assay in healthy subjects.

Pierre Fabre Dermatologie represented by Institut de Recherche Pierre Fabre0 个研究点目标入组 40 人开始时间: 2009年3月16日最近更新: 2019年1月7日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 40

研究概览入排标准研究者记录与标识符相似试验

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

•The subjects must fulfil all the following criteria to enter the study:
•1.Female or male healthy subject.
•2.Subject aged between 18 and 50 years old.
•3.Subject with skin type II to IV on the Fitzpatrick scale
•4.Subject non smoking or smoking less than 5 cigarettes/day.
•5.Subjects demonstrating adequate vasoconstriction to topical corticosteroids ( i.e. responders) Diprosone® cream (non-occlusive application of the reference for 4-6 hours screening pre-test must show a visual score of at least one unit (visual scale (0-4)).
•6.Subject’s condition allowing accurate evaluations and study procedures, at the own Investigator’s judgment (e.g. non-excessive hair on tested areas).
•7.For women:
•7.1.of childbearing potential who practices an effective method of contraception for at least 2 months before the study and one month after the end of the study and during the study with one of the following methods: oral contraception, Intra Uterine Device, injectable or implantable contraception;
•7.2.of childbearing potential who has a negative urinary pregnancy test before final enrolment;
•7.3.of non-childbearing potential, i.e. postmenopausal (absence of menstrual bleeding for 1 year, or 6 months if laboratory confirmation of hormonal status), or who had a hysterectomy, bilateral tubal ligation or bilateral ovariectomy.
•8.Subject willing and able to comply with the requirements of the protocol. In particular, the Subject must adhere to the visit schedule and complete the study.
•9.Subject who has understood and signed a written Informed Consent Form.
•10.Subject affiliated to the French National Health system.
•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

•The subjects who present at least one of the following criteria will not be allowed to enter the study:
•1.Pregnant women, nursing mother, or female planning a pregnancy.
•2.Any systemic disorder (e.g. clinically significant hypertension or circulatory disease), following Investigator judgment that may interfere with interpretation of the study results.
•3.Any skin disease on tested areas, (e.g. active atopic dermatitis, known contact dermatitis, psoriasis, any type of skin infection, ulcer lesion), that may interfere with interpretation of the study results.
•4.Subject with known sensitivity to topical drugs related to any component of any of the formulations being tested (for list of product ingredients see Investigational Brochure and Package insert for marketed corticosteroids).
•5.Subject who takes treatment acting on vascular tone (e.g. nitrates derivatives, antihypertensives antihistamines, OTC cough/cold products containing antihistamines and/or either phenypropanolamine or phentolamine etc).
•6.Subject with any obvious difference in colour between arms.
•7.Subject who takes more than 500 mg of caffeine per day prior to or during the study (a cup of coffee contains about 85 mg of caffeine).
•8.Subject who would require shaving ventral forearms to insure consistent dose on skin surface.
•9.Subject with clinically significant history of alcoholism or drug abuse.
•10.Subject who did not respect the following wash-out period:-No use of creams, emollient s or similar products to forearms for 24 hours prior to the study or planned during the study.-Topical corticosteroids: 2 weeks-Systemic corticosteroids: 1 month
•11.Subject currently enrolled in an investigational drug or device study or participated in such a study in the past month and is still in the exclusion period.
•12.Hospitalized subject, subject deprived of freedom or adult subject under guardianship.
•13.Subject who has received more than 4500 euros as indemnity for participating in clinical studies within the previous 12 months.

研究者

发起方

Pierre Fabre Dermatologie represented by Institut de Recherche Pierre Fabre

相似试验

尚未招募

3 期

Evaluation of the effectiveness of Raphanus sativus in melasma

IRCT20220223054106N1Tehran University of Medical Sciences25

已完成

2 期

To evaluate the efficacy of antiageing cream.

CTRI/2017/12/011027Dabur India Ltd32

招募中

3 期

Effect of Chelidonium majus and hyoscyamus niger with propolis on psoriasis

IRCT20200516047462N4Kashan University of Medical Sciences88

招募中

3 期

Efficacy and safety evaluation of the cream including Citystem extract and Phytessence extract on reducing skin damage caused by air pollutioSkin damage caused by air pollution.

IRCT20161207031288N14Tehran University of Medical Sciences26

已完成

不适用

The efficacy and safety of new moisturizing cream for dry skin condition and itch reliefDry skin condition in healthy volunteersSkin and Connective Tissue Diseases

ISRCTN46216631Korea Health Industry Development Institute (KHIDI) (South Korea)66