NCT06123572

A Clinical Study to Assess the Safety and Effectiveness of Anti-Ageing and Skin Brightening Gel

A Randomized, Double Blind, Two Arm, Parallel, Placebo-Controlled, Safety and Efficacy Study of Anti-Ageing and Skin Brightening Gel

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: Female
• Age: 35 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Randomized, Interventional, Prospective, Double Blind, Two Arm, Comparative, Parallel, Placebo-Controlled, Safety and Efficacy Study of Anti-Ageing and Skin Brightening Gel. Total of 44 adult female subjects (22 Subjects/Arm) of age 35 - 55 years will be enrolled to get 40 completed subjects (20 Subjects/Arm)

Detailed description

There will be a total of 3 visits in the study. The subject will be instructed to visit the facility as per the below visits Visit 01 (Day 01): Screening, Enrolment and Treatment Start Phase (Week 00) Visit 02 (Day 30): Treatment Phase (Week 04) Visit 03 (Day 60): End of Study (Week 08) The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent. Subjects will be asked to not wear any makeup on the face on screening day. Assessment of efficacy parameters before test products usage will be done on Day 01 after enrolment and after test products usage will be done on Day 30 (± 2 days) and Day 60 (± 2 days) as listed-below. * PGA scoring using Griffiths scale - skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness. * Glogau skin age. * Skin pigmentation scoring. * Skin elasticity: Cutometer Dual MPA 580. * Skin colorimeter CL 400: CIE L\*, a\* b\*, ITA angle, skin brightness, skin pigmentation reduction. * Skin Glossymeter GL200 - skin glow. * Visioscan (C+K instrument): crow's feet area wrinkles, fine lines, skin texture - roughness, dryness, wrinkles, smoothness. * Digital photographs: facial photographs before test products usage on day 1 and post-usage at day 60. * Image-pro software - image analysis day 01 vs day 60 - wrinkles, fine lines, pores. * Subjective product perception assessment regarding the test product's effect on skin firmness, appearance, radiance, acne or skin breakouts, glowing skin tone, blemishes and dark skin patches removal etc.

Conditions

• Wrinkle
• Pigment Skin
• Aging

Interventions

Type	Name	Description
OTHER	Placebo	Placebo Comparator
OTHER	Anti-Ageing and Skin Brightening Gel	Anti-Ageing and Skin Brightening Gel.

Timeline

• Start date: 2023-09-14
• Primary completion: 2023-11-20
• Completion: 2023-12-09
• First posted: 2023-11-09
• Last updated: 2023-12-12

Locations

1 site across 1 country: India