Safety and efficacy assessment of Product on skin

Completed

Conditions: Volunteers with dull skin, pigmentary spots, crowâ€™s feet wrinkles, uneven skin, under eye dark circle, Fitzpatrick skin type III to V

Brief Summary: Objective:

PRIMARY OBJECTIVE To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of even skin tone, reduction in pigmentation (dark spot), radiant skin and skin brightness on healthy male & female subjects.

SECONDARY OBJECTIVE To evaluate the in-vivo efficacy of a skin care formulation in terms signs of ageing: minimize fine lines, smooth skin texture, reducing dark circles and improvement in skin hydration on healthy male & 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)

7. Cutometry

8. Tewametry

9. Sebumetry

10. Mexametry

11. Illustrative photographs of whole face & Â¾ th face under diffused light

Recruitment & Eligibility

Inclusion Criteria

Having dull skin and uneven skin tone 2.
Having pigmentary spot on the face of grade 2 to grade 6 according to the Bazins atlas 3.
Having Crows feet wrinkle of grade 2 and above according to the Bazins atlas 4.
Having visible under eye dark circle 5.
Presenting Fitzpatrick skin type III to V with chromameter i.e. ITAÂ° value between -30Â° & 41Â° on cheek bones.

Exclusion Criteria

Having started, changed or interrupted one hormonal treatment during the past 3 months 2.
Having started, changed or stopped her tobacco consumption in the previous 6 months 3.
Having consumed caffeine-based products, alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements 4.
Having taken a medicinal treatment which could lead to hyper pigmentation in the previous 6 months 5.
Taking oral supplements with major or minor effect on whitening of skin 6.
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 7.
Having applied products with anti-wrinkle action in the 2 weeks preceding the start of the study 8.
Having applied products with a depigmenting/ whitening action in the 4 weeks preceding the start of the study 9.
Having undergone physical and/or chemical treatments of the spots in the previous 6 months 10.
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.

Primary Outcome Measures

Name	Time	Method
Even skin tone,	Baseline, 14 days and 28 days
reduction in pigmentation (dark spot), radiant skin and skin brightness, safety of a skin	Baseline, 14 days and 28 days

Secondary Outcome Measures

Name	Time	Method
Minimize fine	lines, smooth skin texture, reducing dark circles and improvement in skin hydration

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