Safety and efficacy assessment of Product on ski

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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.Between 18 and 50 years of age

4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ?¦.)

Specific criteria

5.44 Subjects representing varied skin types (ideally equal representation of all 4 skin types â?? Oily,

Normal, Dry and Combination)+13 sensitive skin (declared through lactic acid sting test).

6.Having wheatish to dark complexion.

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)

9Having 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

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.Do not take part in any family planning activities leading to pregnancy and breastfeeding

16.Do not take part in another study liable to interfere with this study

17.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)

18.Do not change her cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit

19.During the study: Do not use other cosmetic products than the tested products to the studied areas (only usual cleanser/soap is accepted)

20.The day of the measurements: No test product must be used (only face cleaned with water is

accepted)

21.Having started, changed or stopped a hormonal treatment (hormonal contraception, Hormone

Replacement Therapy) in the past 3 months.

22.Having started, changed or stopped her tobacco consumption (for smokers consuming more than

10 cigarettes per day) in the previous 6 months

23.Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoÃ¯n,

amiodarone, metals, minocyclineâ?¦) in the previous 6 months

24.Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, betaï¿¾

caroteneâ?¦)

25.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

26.Having applied products with anti-wrinkle action (Retinoic acid, retinol, retinaldehyde,

isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study

27.Having applied products with a depigmenting action (hydroquinone or derivatesâ?¦) in the 4 weeks

preceding the start of the study.

28.H

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Skin Brightening Effect.Timepoint: Baseline,30 minutes ,7 days,14 days and 28 days

Secondary Outcome Measures

Name	Time	Method
Improvement in Skin Water Barrier Function and Skin Smoothness.Timepoint: Baseline,30 minutes,7 days,14 days and 28 days

Updated 5/1/2023

Safety and efficacy assessment of Product on ski

Recruitment & Eligibility

Study & Design

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