Evaluation of safety & Efficacy of skin care formulatio

Not Applicable

Completed

• Registration Number: CTRI/2022/05/042503
• 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: 2022-06-17
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 33

Inclusion Criteria

1)Indian 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 crows feet wrinkles, fine lines & visibly loose skin

Exclusion Criteria

1Female subjects who are pregnant (determined by Urine pregnancy test) or breastfeeding or having stopped to breastfeed in the past three months

2Having refused to give her assent by not signing the consent form

3Taking part in another study liable to interfere with this study

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.

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 consumed caffeine-based products (coffee, cola, tea â?¦), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements

13Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.

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

15Having applied a cosmetic product (included make-up) or skin care product on the studied areas on the day of the study (only face cleaned with water is accepted)

16Refusing 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 consume any caffeine-based products (coffee, cola, tea â?¦), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements, 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 or skin care products other 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 test site cleaned with water is accepted)

17Having started, changed or stopped a Hormone Replacement Therapy in the past 6 months.

18Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months.

19Having taken a Dehydroepiandrosterone based treatment in the previous 6 months.

20Having applied products with an anti-wrinkle action particularly firming products (Retinoic acid, retinol, retinaldehyde, Alpha Hydroxy Acidâ?¦.) in the 2 weeks preceding the start of the study.

21Having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxinâ?¦) in the previous 12 months.

22Having undergone techniques with aesthetic aim (chemical peel, mechanical dermabrasion, laser, pul

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety, reduction in appearance of wrinkles & fine lines & visible improvement in skin firmness, skin moisturization, skin plumpness & skin smoothnessTimepoint: baseline, 8 hours after product application, 7 days, 14 days,28 days

Secondary Outcome Measures

Name	Time	Method
ILTimepoint: NI