Clinical and Instrumental Evaluation of a Topical "Antiage" Formulation for the Face
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Derming SRL
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Wrinkles profilometry (Ra - micrometers)
研究概览
简要总结
Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the "antiage" activity of Gynomunal® gel after one single application on the face (short term evaluation) and 4 weeks of repeated use twice daily (long term evaluation) by healthy female volunteers.
It is also aim of this study to evaluate cosmetic acceptability by the volunteers and efficacy and tolerance both by investigator and volunteers.
详细描述
Controlled clinical trial that foresees the application of the study product for an uninterrupted period of 4 weeks. 4 visits will be performed: a basal visit (T0), a short term evaluation 20 minutes after the 1st product application (T20min) and a long term evaluation after 2 (T2 - intermediate visit) and 4 (T4 - final visit) week-treatment.
The study will be conducted on 33 healthy volunteers of female sex, 11 women for each of the following groups:
- 35-44 years
- 45-54 years
- 55-65 years The volunteers accept to respect the rules fixed in the list of recruitment criteria and not to deviate from their normal life habits. Moreover, the month preceding the inclusion visit and during the entire period of treatment, normal cleansing habits must be maintained, sun and UV light exposure, avoided. In the case of UV exposure must be used a sun screen total block cream.
Each volunteer is precisely informed about the study, a consent form being completed and signed. At the end of the study the investigator will declare to have informed all the volunteers participating it, signing and dating the relative form.
The study will be started only after Independent Ethical Committee approval. It is understood that the treatment would be immediately interrupted as soon as the investigator judges it necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female healthy subjects;
- •age 35-65 years;
- •presence of light-moderate face ritidosis;
- •agreeing to present at each study visit without make-up;
- •accepting to not change their habits regarding food, physical activity, face cleansing and make- up use;
- •accepting not to expose their face to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study;
- •accepting to sign the Informed consent form
排除标准
- •Pregnancy;
- •lactation;
- •change in the normal habits regarding foods, physical activity, face cleansing and make-up use during the month preceding the test;
- •sensitivity to the test product or its ingredients;
- •subjects whose insufficient adhesion to the study protocol is foreseeable;
- •participation in a similar study actually or during the previous 3 months;
- •change in the normal life habits during the month preceding the inclusion.
- •dermatitis;
- •presence of cutaneous disease on the tested area, as lesions, scars, malformations;
- •recurrent facial/labial herpes;
- •clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.).
- •endocrine disease
- •hepatic disorder
- •renal disorder
- •cardiac disorder
- •pulmonary disease
- •neurological or psychological disease
- •inflammatory/immunosuppressive disease
- •drug allergy.
研究组 & 干预措施
Gynomunal® gel
The study will be conducted on 33 healthy volunteers of female sex aged between 35 and 65 years old; each subject will apply a fixed quantity of the Gynomunal gel on the face (including the submental area) twice a day, in the morning and in the evening (preferentially always at the same hour), with a mild massage.
干预措施: Gynomunal® gel (Drug)
结局指标
主要结局
Wrinkles profilometry (Ra - micrometers)
时间窗: 4 weeks
A picture of crow's feet area is taken thanks to Primos compact portable device (GFMesstechnik); Primos software is able to elaborate 3D representations of skin wrinkles as well as to measure skin principal profilometric parameters in vivo or on skin replicas. As a measuring method Primos compact uses a digital stripe projection based on micro mirrors which allows for fast and highly precise measuring data acquisition (the speed of under 70ms for the measuring data admission provide perfect results of measurement).
次要结局
- Plastoelasticity(4 weeks)
- Electrical capacitance of skin (hydration)(4 weeks)