NCT04545970

A Clinical Study to Evaluate Efficacy and Safety of a Cosmetic Product in the Treatment of Facial Lines

A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of an Anti-Aging Serum in the Treatment of Facial Lines

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Revision Skincare · Industry
• Sex: Female
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This randomized, double-blind, placebo-controlled clinical trial was conducted to assess the efficacy and safety of an anti-aging serum to improve the appearance of expression lines as well as overall skin health of aging skin after 12 weeks of twice-daily use in female subjects, aged 35-60, compared to placebo. A total of 55 subjects completed study participation which included 33 subjects in the active group and 22 subjects in the placebo group.

Detailed description

This randomized, double-blind, placebo-controlled clinical trial is being conducted to assess the efficacy and safety of the anti-aging serum when used over the course of 12 weeks by women with mild to moderate fine lines, wrinkles and overall photodamage on the global face. Efficacy and tolerability will be assess through clinical grading at baseline, weeks 4, 8, and 12. Efficacy evaluation on fine lines and wrinkles through clinical grading will also be performed at 15 minutes post product application. Self-assessment questionnaires and VISIA photography will be completed at baseline, weeks 4, 8, and 12. 3D PRIMOS photography will be performed at baseline, weeks 8 and 12. A total of 55 subjects completed study participation which included 33 subjects in the active group and 22 subjects in the placebo group.

Conditions

• Fine Lines
• Wrinkles
• Photoaging

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Facial cleanser	Facial cleanser to be used by study participants
COMBINATION_PRODUCT	Facial moisturizer	Bland moisturizer to be used by study participants after serum in the evening.
COMBINATION_PRODUCT	Sunscreen	Sunscreen to be applied after application of serum in the morning.

Timeline

• Start date: 2019-12-23
• Primary completion: 2020-03-11
• Completion: 2020-07-06
• First posted: 2020-09-11
• Last updated: 2020-09-16

Locations

1 site across 1 country: United States