Safety and efficacy of skin care formulation

Not yet recruiting

• Conditions: Volunteers with uneven skin tone and dull skin.

• Registration Number: CTRI/2021/08/035607
• Lead Sponsor: Kama Ayurveda Pvt Ltd

Brief Summary

Objective: To evaluate the in vivo efficacy and safetyof a skin care formulation in terms of skin even tone, reduction inpigmentation (dark spots), radiant skin, skin brightening, skin moisturization,minimize fine lines and wrinkles, smooth skin and helps in reduction of darkcircles on healthy male and female volunteers

Duration of study: 28 days study

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

Population: Group 1 36 volunteers

Group 2: 36 volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-09
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Having dull skin and uneven skin tone Having pigmentary spot on the face Having Crows feet wrinkle of grade 2 Having visible under eye dark circle.

Exclusion Criteria

• Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months Having started, changed or stopped her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months Having consumed caffeine-based products (coffee, cola, tea, …), 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 (phenytoïn, amiodarone, metals, minocycline…) in the previous 6 months • Taking oral supplements with major or minor effect on whitening of skin (e.g. vitamin C, beta-carotene…) 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 (Retinoic acid, retinol, retinaldehyde, isotretinoin, A.H.A...) in the 2 weeks preceding the start of the study Having applied products with a depigmenting/ whitening action (hydroquinone or derivates…) in the 4 weeks preceding the start of the study.
• Having undergone physical and/or chemical treatments of the spots (liquid nitrogen, dry ice, pulsed flash lamp, dermabrasion, chemical peel …) 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
Efficacy of the product in terms of skin even tone, reduction in pigmentation (dark spots), radiant skin, skin brightening, skin moisturization, minimize fine lines and wrinkles, smooth skin and helps in reduction of dark circles	T0, T14 days and T28 days

Secondary Outcome Measures

Name	Time	Method
Safety	T0, T14 days and T28 days

Trial Locations

Locations (1)

Mascot Spincontrol India Pvt. Ltd.; 🇮🇳 (Suburban), MAHARASHTRA, India

Mascot Spincontrol India Pvt. Ltd.

🇮🇳(Suburban), MAHARASHTRA, India

Dr Raji Patil

Principal investigator

022-43349191

raji@mascotspincontrol.in