Evaluation of safety & Efficacy of skin care formulatio

Not Applicable

Completed

• Registration Number: CTRI/2022/05/042747
• Lead Sponsor: Transformative Learning Solution Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-07-13
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 34

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 • 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 (phenytoïn,

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 A

Study & Design

• Study Type: Interventional
• Study Design: Not specified