The objective of this study will be to evaluate safety and efficacy of skin care formulation in terms of visible reduction in appearance of fine lines and wrinkles, visible reduction in density of dark spots, improvement in skin moisturization, improvement in skin firmness, improvement in skin brightening, smoothness, even skin tone & softness on healthy female subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Visible reduction in appearance of fine lines and wrinkles, visible reduction in density of dark spots, improvement in skin moisturization, improvement in skin firmness, improvement in skin brightening, smoothness, even skin tone & softness
研究概览
简要总结
PRIMARY OBJECTIVE: The objective of this study will be to evaluate safety and efficacy of skin care formulation in terms visible reduction in appearance of fine lines and wrinkles, visible reduction in density of dark spots, improvement in skin moisturization, improvement in skin firmness, improvement in skin brightening, smoothness, even skin tone & softness on healthy female subjects.
SECONDARY OBJECTIVE: Secondary objective is to evaluate the safety & efficacy of a skin care formulation in terms of reduction in circumference of inner upper arm.
TestpProduct : TRAHNNA HEART-LEAVED MOONSEED PROTECTIONIST BODY SOOTHER-100 ML
The evaluation is performed using: Subject’s Self Evaluation, Dermatological Evaluation: Safety, Dermatological Evaluation: Efficacy, Measurement of circumference of inner upper arms, Chromametry (L* parameter for skin brightness & DE parameter for skin even tone) , Cutometry (R0 parameter for skin firmness) , Corneometry (Capacitance parameter Skin Moisturization)
Total duration of the study: 60 days following the first application of product.
Kinetics: T0, T immediate after product application, T+15 days after Product application, T+28 days after Product application, T+45 days Product application & T+60 days after Product application
Number of volunteers: 36 female subjects will be selected for the study.
aged between 35 and 55. years old,having crow’s feet wrinkles & fine lines of grade 2-4 and Pigmentary dark spot & loose skin (face, neck & inner upper arms).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Indian Female subjects
- •Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup) 3.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) 4.Having crows feet wrinkles, fine lines of grade 2-4 & Pigmentary dark spots.
- •5.Having loose skin(face, neck and upper arms).
排除标准
- •Female subjects who are pregnant or breastfeeding or having stopped to breastfeed in the past three months 2.Having refused to give her assent by not signing the consent form
- •Taking part in another study liable to interfere with this study
- •Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
- •Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •Being epileptic.
- •Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •Having cutaneous hypersensitivity
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 10.Having known allergy to any of the Ingredient of the Test Product
- •Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
- •Having consumed caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements
- •Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
- •Having applied a cosmetic product (included make-up) or skin care product on the studied areas on the day of the study (only face cleaned with water is accepted)
- •Refusing to follow the restrictions below during the study: -Do not take part in any family planning activities leading to pregnancy and breastfeeding , -Do not take part in another study liable to interfere with this study, -Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol),- Do not consume any caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements, -Do not change her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit, -During the study: Do not use other cosmetic products or skin care products other than the tested products to the studied areas. (only usual cleanser/soap is accepted), -The day of the measurements: No test product must be used (only test site cleaned with water is accepted)
- •Having started, changed or stopped a Hormone Replacement Therapy in the past 6 months.
- •Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months.
- •Having taken a Dehydroepiandrosterone based treatment in the previous 6 months.
- •Having applied products with an anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, Alpha Hydroxy Acid….) in the 2 weeks preceding the start of the study.
- •Having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxin…) in the previous 12 months.
- •Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp …) in the previous year.
- •Having undergone surgery of the skin-muscular slackening on the face (lifting) in the previous 5 years.
- •Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…)
- •Having applied products with a depigmenting action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
- •Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel …) in the previous 6 months.
- •Having a suntanned skin on the studied areas which could interfere with the evaluations of the study. 28.Having had beauty treatment (e.g. scrub, self-tanning product …) on the studied areas in the previous week. 29.Having practiced sport, the day of start of the study.
- •Refusing to follow the restrictions below during the study:.
- •Do not start, change or stop a hormonal treatment (hormonal contraception, Hormone Replacement Therapy),.
- •Do not start a medicinal treatment which could lead to hyper pigmentation,.
- •Do not use products or techniques or surgery with an anti-wrinkles/ anti ageing action /firming action and depigmenting/ whitening action,.
- •Do not start an oral or local retinoid-based treatment,.
- •Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) or apply self-tanning products,.
- •Do not practice sport the days of study,.
- •Do not expose herself to the sun by respecting a strict photo-protection.
结局指标
主要结局
Visible reduction in appearance of fine lines and wrinkles, visible reduction in density of dark spots, improvement in skin moisturization, improvement in skin firmness, improvement in skin brightening, smoothness, even skin tone & softness
时间窗: Baseline, Immediate after application, 15 days, 28 days, 45 days & 60 days
次要结局
- Reduction in circumference of inner upper arm(Baseline, Immediate after application, 15 days, 28 days, 45 days & 60 days)