Safety and efficacy assessment of Product on skin

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 36

Inclusion Criteria

1.Indian 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 55 years of age.
4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ€¦.).

Exclusion Criteria

1.Being pregnant or breastfeeding or having stopped to breastfeed in the past three months. 2.Having refused to give her/his assent by signing the consent form 3.Taking part in another study liable to interfere with this study 4.Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months) 5.Being asthmatic. 6. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex 7.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). 8.Having cutaneous hypersensitivity. 9.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 10.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 11.Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. 12.Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted) 13.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 change his/her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit.
Do not practice water activities (swimming pool, sauna, hammam, balneotherapy).
During the study: Do not use other cosmetic products than the tested products to the studied areas. Do not use hair oil.
The day of the measurements : No other cosmetic products must be used (only face cleaned with water is accepted) 14.Having started, changed or stopped a Hormone Replacement Therapy in the past 6 months. 15.Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months. 16. Having taken a Dehydroepiandrosterone based treatment in the previous 6 months. 17.Having applied products with an anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, Alpha Hydroxy Acidâ€¦.) in the 2 weeks preceding the start of the study. 18.Having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxinâ€¦) in the previous 12 months. 19. Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp â€¦) in the previous year. 20. Having undergone surgery of the skin-muscular slackening on the face (lifting) in the previous 5 years. 21.Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-caroteneâ€¦) 22. Having applied products with a depigmenting action (hydroquinone or derivatesâ€¦) in the 4 weeks preceding the start of the study. 23. Having 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. 24.Having consumed caffeine-based products (coffee, cola, tea â€¦), alcohol, and highly spiced foods and/or smoked in the two hours preceding the measurements. 25. Having a suntanned skin on the studied areas which could interfere with the evaluations of the study. 26.Having had beauty treatment (e.g. scrub, self-tanning product â€¦) on the studied areas in the previous week. 27. Having practiced sport, the day of start of the study. 28.Having a suntanned skin on the studied areas which could interfere with the evaluations of the study. 29. 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 DHEA-based treatment.
Do not expose himself/herself to the sun with the intention to sunbathe (activities outside which do not last too much time are authorized).
Do not start an oral or local retinoid-based treatment.
Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask â€¦) or apply self-tanning products.
Do not consume caffeine-based products (coffee, cola, tea â€¦), alcohol, highly spiced foods nor smoke in the two hours preceding the measurements each day of study.
Do not practice sport the days of study.
Do not expose yourself to the sun by respecting a strict photo-protection.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in fine lines and wrinkles, reduction in density of dark spots (age spots), improvement in skin moisturization, improvement in skin brightening and improvement in skin firmness	Baseline, 28 days, 56 days & 84 days

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