Evaluation of safety & Efficacy of skin care formulation

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 36

Inclusion Criteria

1)Indian or Asian 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)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) 4) Having uneven skin tone 5) Having Crows feet wrinkle according to the Bazins atlas.

Exclusion Criteria

1Being pregnant or breastfeeding or having stopped to breastfeed in the past three months â€¢ Having refused to give her assent by signing the consent form 2Taking part in another study liable to interfere with this study 3Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area 4Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months) 5Having a progressive asthma (either under treatment or last fit in the last 2 years) 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 or food products or to latex 10Having known allergy to any of the Ingredient of the Test Product.
11Following 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) 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) on the studied areas the first 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 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 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 face cleaned with water is accepted) 16Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone 17Replacement Therapy) during the past 3 months 18Having started, changed or stopped her tobacco consumption (for smokers consuming more than 1910 cigarettes per day) in the previous 6 months 20Having consumed caffeine-based products (coffee, cola, tea), alcohol, highly spiced food 21and/or not smoke in the two hours preceding the measurements 22Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoÃ¯n, 23amiodarone, metals, minocyclineâ€¦) in the previous 6 months 24Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta caroten) 25Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask) or having applied self-tanning products in the week preceding the start of the study 26Having 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.
27Having applied products with a depigmenting/ whitening action (hydroquinone or derivatesâ€¦) in 28the 4 weeks preceding the start of the study.
29Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, 30pulsed flash lamp, dermabrasion, chemical peel â€¦) in the previous 6 months 31Having a suntanned skin on the studied areas which could interfere with the evaluations of the 32Study 33Refusing 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 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 use products or techniques or surgery with a depigmenting action, Do not practice water activities (swimming pool, sauna, hammam, balneotherapy), 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 appearance of wrinkles & fine lines, improvement in skin brightness, skin even	baseline, 8 hours after product application, 7 days, 14 days,28 days
tone and skin moisturization, product safety	baseline, 8 hours after product application, 7 days, 14 days,28 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