Safety and efficacy of skin care formulation

Recruiting

Conditions: Volunteers having dull skin, pigmentary spots, crowâ€™s feet wrinkles, uneven skin tone and visible under eye dark circles

Registration Number: CTRI/2022/01/039184

Lead Sponsor: Kama Ayurveda Pvt Ltd

Brief Summary: Objective:

PRIMARY OBJECTIVE To evaluate the in-vivo efficacy andsafety of a skin care formulation in terms of even skin tone, reduction inpigmentation (dark spot) & radiant skin on healthy male & femalesubjects.

SECONDARY OBJECTIVE To evaluate the in-vivo efficacy of askin care formulation in terms signs of ageing: minimize fine lines, smoothskin texture, reducing dark circles and improvement in hydration on healthymale & female subjects

Duration of study: 28 days study

Kinetics: T0, T+14 days and T+28 days

Population: 36 (18 Females & 18 Males) volunteers

The evaluation is performed using:

1. Subjectâ€™s Self Evaluation,

2. Dermatological Evaluation: Cosmetic Acceptability,

3. Dermatological Evaluation: Efficacy

4. Chromametry

5. Corneometry

6. CLBT (Color, Luminosity, Brightness, Transparency)

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 36

Inclusion Criteria

Having dull skin and uneven skin tone Having pigmentary spot on the face of grade 2 to grade 6 according to the Bazins atlas Having Crows feet wrinkle of grade 2 and above according to the Bazins atlas Having visible under eye dark circle.

Exclusion Criteria

Having started, changed or interrupted one hormonal treatment during the past 3 months Having started, changed or stopped her tobacco consumption in the previous 6 months Having consumed caffeine-based products, alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements Having taken a medicinal treatment which could lead to hyper pigmentation in the previous 6 months Taking oral supplements with major or minor effect on whitening of skin 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 Having applied products with anti-wrinkle action in the 2 weeks preceding the start of the study Having applied products with a depigmenting/ whitening action in the 4 weeks preceding the start of the study Having undergone physical and/or chemical treatments of the spots in the previous 6 months Having a suntanned skin on the studied areas which could interfere with the evaluations of the study For males, having not shaved their beard 24 hours prior to the day of measurement.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evaluate of efficacy and safety of a skin care formulation in terms of even skin tone, reduction in pigmentation (dark spot), radiant skin	T0, T14 days and T28 days

Secondary Outcome Measures

Name	Time	Method
efficacy of a skin care formulation in terms signs of ageing: minimize fine	lines, smooth skin texture, reducing dark circles and improvement in hydration

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