Assessment of safety & Efficacy of cosmetic product

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 36

Inclusion Criteria

1)Indian / 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 scarâ€¦.) Specific criteria 4)Having pigmentory dark spots on face.

Exclusion Criteria

1)Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2)Having refused to give her assent by signing the consent form 3)Taking part in another study liable to interfere with this study 4)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area 5)Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months) 6)Having a progressive asthma (either under treatment or last fit in the last 2 years) 7)Being epileptic 8)Having non-stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 9)Having cutaneous hypersensitivity 10)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex. Having known allergy to any of the Ingredient of the Test Product. 11)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) 12)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 13)Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit 14)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) 15)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 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) 16)Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months 17)Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months 18)Having consumed caffeine-based products (coffee, cola, tea, â€¦), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements 19)Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoÃ¯n, amiodarone, metals, minocyclineâ€¦) in the previous 6 months 20)Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta caroteneâ€¦) 21)Having 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 22)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. 23)Having applied products with a depigmenting/ whitening action (hydroquinone or derivatesâ€¦) in the 4 weeks preceding the start of the study. 24)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 25)Having a suntanned skin on the studied areas which could interfere with the evaluations of the study 26)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 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 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
Improvement in skin	Baseline, 15 days, 28 days, 45 days & 60 days
brightness	Baseline, 15 days, 28 days, 45 days & 60 days

Secondary Outcome Measures

Name	Time	Method
Improvement in skin smoothness, skin softness, skin moisturization, skin firmness, reduction in pigmentory dark spots	Baseline, 15 days, 28 days, 45 days & 60 days

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