Safety and efficacy assessment of Product

Not yet recruiting

• Conditions: having visible melasma, crows feet wrinkles of grade 2 and above.

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

Brief Summary

**OBJECTIVE**:The objective of this study will be to evaluate the in-vivo safety and efficacyofskin care formulations on healthy female subjects

**Primary Objective:**To study the safety and efficacy of a skin care formulation in terms ofreduction of melasma.

**Secondary Objective:**To study the efficacy of all the test products in terms of improvement in skinmoisturization, skin firmness and skin brightening & reduction in densityof wrinkles and fine lines.

The evaluation is performedusing:

1       SubjectSelf Evaluation (SSE)

2       DermatologicalEvaluation: Cosmetic Acceptability

3       DermatologicalEvaluation: Efficacy

4       Chromameter

5      Cutometer

6       Corneometer

7       Illustrativephotographs of whole face under diffused ligh

The study will last 56 days following the firstapplication of the product

Kinetics: Screening , T0, T+28days and T+56 days

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 12

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, thyroid…) 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 …) 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, …), 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

Primary Outcome Measures

Name	Time	Method
Reduction of melasma, Products safety on skin	28 days, 56 days

Secondary Outcome Measures

Name	Time	Method
Improvement in skin moisturization, skin	firmness and skin brightening & reduction in density of wrinkles and fine lines

Trial Locations

Locations (1)

Mascot Spincontrol India Pvt. Ltd.; 🇮🇳 Mumbai, MAHARASHTRA, India

Mascot Spincontrol India Pvt. Ltd.

🇮🇳Mumbai, MAHARASHTRA, India

Dr Raji Patil

Principal investigator

02243349191

raji@mascotspincontrol.in