Evaluation and Comparison of safety & Efficacy of four skin care formulations

Not yet recruiting

• Conditions: The subjects selected for this study are healthy females aged between 35-55 years of age having crows feet wrinkles of grade 2-4 & having visible dry skin and wrinkles.

• Registration Number: CTRI/2022/01/039692
• Lead Sponsor: MERCK PERFORMANCE MATERIALS PVT LTD

Brief Summary

Objective: The objective of this study will be to evaluate & compare the in-vivo safety and efficacy of four skin care formulations in terms of reduction of wrinkles on healthy female subjects.

The evaluation is performed using:

1. Subject Self Evaluation (SSE)

2. Dermatological Evaluation: Cosmetic Acceptability

3. Dermatological Evaluation: Efficacy

4. Chromameter

5. Cutometer

6. Corneometer



The study will last 56 days following the first application of the product



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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-01-21
• Study Start: 2022-01-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

• Indian Asian female subjects 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 Between 35 and 55 years of age.
• Skin is healthy on the studied anatomic unit free of eczema, wounds, inflammatory scar Subject having Crows feet wrinkle of grade 2 and above according to the Bazins atlas.
• using Page number 40 of Skin Ageing Atlas Subject having visible dry skin.

Exclusion Criteria

• Having started, changed or stopped a hormonal treatment in the past 3 months.
• Having taken an oral retinoid-based treatment in the past 6 months Having taken a local retinoid-based treatment on the studied areas in the previous month Having had beauty treatment in the previous week Having practiced water activities in the previous week.
• Having consumed caffeine-based products, alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements Having practiced intensive sports during the day prior to the T0 measurements Having wounds, Scars, sunburns, tattoos and piercing on test site.
• Having hair on test site.
• Having applied another product than water on the studied areas in the morning of the T0 measurements Having had an intensive UV exposition on the inner forearm prior to T0 measurements Having 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
To study the safety and efficacy of a skin care formulation in terms of reduction of wrinkles	T0, T28days, T56days

Secondary Outcome Measures

Name	Time	Method
To study the efficacy of all the test products in terms of reduction in density of dark spots &	improvement in skin moisturization, skin firmness and skin brightening

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