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
- 2
- 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.
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