Efficacy and Tolerance Evaluation of a "Revitalizing" Face Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Derming SRL
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change of skin resistance to pinching clinical score
研究概览
简要总结
Efficacy and Tolerance Evaluation of a"revitalizing" face treatment consisting of a day and a night cream
详细描述
Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the activity of a "revitalizing" face treatment consisting of a day and a night cream, applied for an uninterrupted period of 3 months, by female volunteers, aged 35-60 years, with aging/photo aging of moderate grade.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female sex,
- •age 35-60 years,
- •Caucasian subjects,
- •presence of moderate face ritidosis,
- •agreeing to present at each study visit without make-up,
- •accepting to follow the instructions received by the investigator,
- •accepting to not change their habits regarding food, physical activity, face cleansing and make- up use,
- •agreeing not to apply or take any product or use face massages or other means known to improve skin wrinkle and skin qualities during the entire duration of the study,
- •accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study,
- •no participation in a similar study currently or during the previous 3 months
- •accepting to sign the Informed consent form.
排除标准
- •Pregnancy,
- •lactation,
- •sensitivity to the test products or their ingredients (to be assessed by the investigator during the baseline visit),
- •subjects whose insufficient adhesion to the study protocol is foreseeable.
- •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.
- •anti-inflammatory drugs, anti-histaminic, topic (application on the face) and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of hormonal treatment starting more than 1 year ago),
- •using of drugs or dietary supplements able to influence the test results in the investigator opinion.
研究组 & 干预措施
Nutriage SPF 30 day cream and Nutriage night cream
Application of the study products (day cream at the morning and night cream at the evening), for an uninterrupted period of 3 months.
干预措施: Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy) (Other)
结局指标
主要结局
Change of skin resistance to pinching clinical score
时间窗: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important 1. = important 2. = moderate 3. = weak 4. = very weak
Change of skin recovery after pinching clinical score
时间窗: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important 1. = important 2. = moderate 3. = weak 4. = very weak
Change of skin dryness clinical score
时间窗: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Clinical evaluation of skin dryness was performed according to the following score: 0 = very hydrated skin 1. = hydrated skin 2. = normal skin 3. = kindly dry skin 4. = dry skin 5. = very dry skin
Change of wrinkles grade, around the eyes (Crow's feet)
时间窗: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Variation of wrinkles grade from baseline of the Glogau's reference photographic scale (visual score from 1-4) where: * Type 1: early wrinkles * Type 2: wrinkle in motion * Type 3: wrinkles at rest * Type 4: Only wrinkles
Change of wrinkles grade of nasolabial folds
时间窗: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Variation of wrinkles grade from baseline of the Lemperle's reference photographic scale (visual score from 1-6) where: * Grade 1: no wrinkles * Grade 2: just perceptible wrinkles * Grade 3: shallow wrinkles * Grade 4: moderately deep wrinkles * Grade 5: deep wrinkles, well-defined folds * Grade 6: very deep wrinkles, redundant fold
Change of skin surface microrelief's regularity
时间窗: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Variation of skin surface microrelief's regularity grade from baseline of cheek surface microrelief photographic scale where: * Grade 1:very regular * Grade 2: regular * Grade 3: irregular * Grade 4: very irregular.
Change of vascular and pigmentary homogeneity clinical score
时间窗: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
Homogeneity grade was determined according to specific reference clinical and photographic scales and to the following clinical score: 0 = very homogeneous 1. = homogeneous 2. = quite not homogeneous 3. = not homogeneous 4. = very not homogeneous 5. = marked not homogeneous
Change of skin resistance to traction clinical score
时间窗: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important 1. = important 2. = moderate 3. = weak 4. = very weak
次要结局
- Change of roughness profilometric parameters(Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3))
- Photographic documentation (3D pictures)(Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3))