MedPath

Assessment of Safety & Efficacy of cosmetic products

Not Applicable
Registration Number
CTRI/2023/10/058458
Lead Sponsor
EMAMI LTD.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Indian female subjects

2.Healthy subjects

3.Skin is healthy on the studied anatomic unit

4.Having dull skin with dark spots (acne PIH)

5.Having under eye dark circle

6.Having dark to wheatish skin

7.Having oily to mixed oily skin type.

8.Having daily routine involving atleast 2 hours sun exposure

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 not 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 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)

6 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.

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 undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.

10 Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.

11 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)

12 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 their 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, The day of the measurements: No test product must be used (only face cleaned with water is accepted)

13 Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months

14 Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months

15 Having consumed caffeine-based products (coffee, cola, tea, …), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements.

16 Having taken a medicinal treatment which could lead to hyper pigmentation (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months.

17 Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…)

18 Having 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

19 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

20 Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.

21 Having a suntanned skin on the studied areas which could interfere with the evaluations of the study

22 Refusing to follow the restrictions below during the study:Do not start, ch

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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