Evaluation of safety & Efficacy of skin care formulatio

Not Applicable

Completed

• Registration Number: CTRI/2022/06/043455
• 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: 2022-08-05
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 35

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

1 Being pregnant or breastfeeding or having stopped to breastfeed in the past three months • Having refused to give her assent by signing the consent form

2 Taking part in another study liable to interfere with this study

3 Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area

4 Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)

5 Having a progressive asthma (either under treatment or last fit in the last 2 years)

6 Being epileptic

7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)

8 Having cutaneous hypersensitivity

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

10 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, HormoneReplacement 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), 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 (phenytoïn,amiodarone, metals, minocycline�) in the previous 6 months

20 Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta caroten)

21 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

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

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 <br/ ><br>tone and skin moisturization, product safetyTimepoint: baseline, 8 hours after product application, 7 days, 14 days,28 days

Secondary Outcome Measures

Name	Time	Method
ILTimepoint: NI