Tolerance and Efficacy Evaluation of Three Face Creams in Subjects Undergoing to Injection Procedure With Hyaluronic Acid (Intradermal Implant)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Tolerance and the efficacy on skin comfort of F#1048-082 soothing cream used just after injection procedure on nasolabial folds
研究概览
简要总结
The study will evaluate the tolerance and the efficacy on skin comfort of F#1048-082 soothing cream used just after injection procedure and also the tolerance and the efficacy of the F#841-020 anti-age cream on aging parameters compared to baseline and to the F#1374-002 placebo cream (comparison within subjects - half face method) to identify additional benefits delivered by the product compared to a cosmetic procedure.
详细描述
First study phase (soothing activity)
- Clinical grading (visual analogic scale):
- Erythema (0= no erythema to 10= strong erythema)
- Oedema (0= no oedema to 10= strong oedema)
- Bruise (0= no bruise to 10= strong bruise)
- Overall skin appearance (0= bad overall appearance to 10= good overall appearance).
- Optical colorimetry: measurement of redness/bruise (L*a*b*) by Spectrophotometer CM-2600d.
- Photographic documentation: Canfield imaging station equipped with visible, polarized, fluorescence and UV light and with specific lighting for shadows.
Second study phase (anti-age activity vs placebo):
- Clinical and self grading (visual analogic scale) :
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female gender
- •age > 35 years old
- •good general state of health
- •woman who had already undergone Hyaluronic acid injections
- •woman who have not applied any retinoid product in the last 3 months
- •woman who are not in a recovery period after laser/peeling/acne treatment
- •accepting to return to the centre for the planned visits
- •accepting to follow the investigator's instructions during the entire study period
- •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
- •agreeing to not receive any drug able to change the skin characteristics during the entire duration of the study
- •accepting to not receive any cutaneous anti-age treatment 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
- •accepting to sign the Informed consent form.
排除标准
- •Pregnancy (only for subjects not in menopause)
- •lactation (only for subjects not in menopause)
- •subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
- •subjects not in menopause who do not accept to perform the pregnancy test during the basal visit (T0), 6 and 12 weeks after the intradermal implant execution;
- •subjects participating to a similar test less than 3 months ago
- •sensitivity to the test products or theirs ingredients
- •subjects whose insufficient adhesion to the study protocol is foreseeable.
- •dermatitis
- •presence of cutaneous disease on the tested area as lesions, scars, malformations.
- •clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.)
- •recurrent facial/labial herpes.
- •endocrine disease
- •hepatic disorder
- •renal disorder
- •cardiac disorder
- •pulmonary disease
- •digestive disease
- •haematological disease
- •chronic phlogosis or autoimmune disease
- •neurological or psychological disease
- •drug allergy.
- •systemic corticosteroids
- •retinoid products in the previous 3 months and during the entire study period
- •aspirin or non-steroid anti-inflammatory drugs (FANS)
- •anti-histaminic, narcotic, antidepressant, immunosuppressive drugs (with except, for female subjects, of contraceptive or hormonal treatment starting from at least one year)
- •assumption of drugs able to influence the test results in the investigator opinion.
研究组 & 干预措施
Skin aging
Anti-age product will be applied once a day, in the evening, on half face and neck for an uninterrupted period of 12 weeks and the placebo cream in the morning with the same modalities. On the contralateral face side (right or left side according to a previous randomisation list), the volunteers will apply the placebo cream twice a day
干预措施: Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002) (Other)
结局指标
主要结局
Tolerance and the efficacy on skin comfort of F#1048-082 soothing cream used just after injection procedure on nasolabial folds
时间窗: 1 week
For 7 days after injections (from T0 to T7d/T0'') the soothing cream will be applied twice a day on the full face and neck insisting on injection areas. 5 visits will be performed: a pre-test visit (T-30 subjects' screening), a baseline visit (T0 intradermal implant execution/ T0' evaluations just after the aesthetic procedure/ Timm evaluations immediately after the 1st soothing cream application), 2 intermediate visits (T1d, T3d - 1 and 3 days after injections) and a final visit (T7d - 7 days after the aesthetic procedure). Product tolerance (number of participants with adverse events) and efficacy: * clinical and self grading (performed on injection areas by VAS score) * optical colorimetry (on nasolabial folds - L\*a\*b\*) * photographic documentation (of all the face) will be performed at each study time.
次要结局
- Evaluation of the tolerance and the efficacy of the F#841-020 anti-age cream on aging parameters compared to baseline and to the F#1374-002 placebo cream to identify additional benefits delivered by the product compared to a cosmetic procedure(3 months)
研究者
Adele Sparavigna
Physician
Derming SRL