Safety and efficacy assessment of Product

Not Applicable

• Registration Number: CTRI/2022/05/042920
• Lead Sponsor: MERCK PERFORMANCE MATERIALS PVT LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1Indian or Asian female subjects

2Healthy 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.

3Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) Specific criteria

4Subjects having visible melasma, having crows feet wrinkles of grade 2 and above.

Exclusion Criteria

1Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.

2Having refused to give his/her assent by not signing the consent form and Informed consent form

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

4Being known diabetic case

5Known asthma

6Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)

7Being known thyroid case

8Being epileptic.

9Following a chronic medicinal treatment comprising any of the following products: aspirin based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes or corticosteroid by any route (the only medication permitted is paracetamol)

10Known case of hypersensitivity.

11Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.

12Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.

13Having changed their cosmetic habits except those required by the protocol 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 48 hours prior study

Having started, changed or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy, thyroidâ?¦) in the past 3 months.

16Having taken an oral retinoid-based treatment in the past 6 months

17Having taken a local retinoid-based treatment on the studied areas in the previous month

18Having had beauty treatment (e.g. scrub, manicure, self-tanning product â?¦) in the previous week

19Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week.

20Having consumed caffeine-based products (coffee, cola, tea, â?¦), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements

21Having practiced intensive sports during the day prior to the T0 measurements

22Having wounds, Scars, sunburns, tattoos and piercing on test site.

23 Having hair on test site.

24Having applied another product than water on the studied areas in the morning of the T0 measurements

25Having had an intensive UV exposition on the inner forearm (solariums, sun) prior to T0 measurements.

26Having used cosmetic product on the studied area during 24 hours prior to T0 measurements.

Study & Design

• Study Type: Interventional
• Study Design: Not specified