Safety and efficacy assessment of Product on skin

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

1.Indian Male and female subjects 2.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.Between 35 and 50 years of age.
4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) Specific criteria 5.Having mild to moderate crows feet wrinkles according to the Bazins atlas.
[using Page nÂ° 40 & 41 of Skin Ageing Atlas (Scale: 0 to 6)].
6.Having visible under eye dark circles.
7.Having under eye wrinkles of grade 2 to 4 according to the Basins atlas [ using Page nÂ° 46 and 47 under eye Wrinkles of Skin Ageing Atlas (Scale 0 to 8)] 8.Having visible Fine lines.

Exclusion Criteria

1For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2Having refused to give her assent by not signing the consent form 3Taking part in another study liable to interfere with this study 4Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 5Having a progressive asthma. 6Being epileptic. 7Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8Having cutaneous hypersensitivity 9Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 10Following 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) 11Having consumed caffeine-based products (coffee, cola, tea â€¦), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements 12Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 13Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit 14Having applied a cosmetic product (included make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted) 15Refusing 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 change their cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit. Do not have acne prone skin. During the study: Do not use other cosmetic products than the tested products to the studied areas. The day of the measurements: No test product must be used (only face cleaned with water is accepted) 16Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months 17Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months 18Having consumed caffeine-based products (coffee, cola, tea, â€¦), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements 19Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoÃ¯n, amiodarone, metals, minocyclineâ€¦) in the previous 6 months 20Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta caroteneâ€¦) 21Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask â€¦) or having applied self-tanning products in the week preceding the start of the study 22Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study 23Having applied products with a depigmenting/ whitening action (hydroquinone or derivatesâ€¦) in the 4 weeks preceding the start of the study. 24Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel â€¦) in the previous 6 months 25Having a suntanned skin on the studied areas which could interfere with the evaluations of the study. 26Refusing 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 take oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-caroteneâ€¦).
Do not consume caffeine-based products (coffee, cola, tea, â€¦), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements.
Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask â€¦) or apply self tanning products.
Do not use products or techniques or surgery with a depigmenting / whitening action.
Do not expose herself to the sun by respecting a strict photo-protection.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety, Reduction in Crowâ€™s feet wrinkles, dark circles & improvement in skin moisturization & skin	Baseline, Day 1, day 3 and Day 28
firmness	Baseline, Day 1, day 3 and Day 28

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Mascot Spincontrol India Pvt. Ltd.
🇮🇳
Mumbai, MAHARASHTRA, India
Mascot Spincontrol India Pvt. Ltd.
🇮🇳Mumbai, MAHARASHTRA, India
Dr Raji Patil
Principal investigator
02243349191
raji@mascotspincontrol.in