NCT04065035

A Clinical Study to Evaluate Efficacy and Tolerability of a Cosmetic Product for Arm Firming

A Double-Blind Split-Body Placebo-Controlled Clinical Study to Evaluate the Efficacy of a Cosmetic Product for Arm Firming

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Revision Skincare · Industry
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This single-center, split-body, double-blind, randomized, controlled clinical trial was conducted to assess the efficacy and tolerance of a topical firming body moisturizer when used over the course of 12 weeks by women with mild to moderate sagging, crepey skin, and overall photodamage on the upper arms. A total of 40 subjects completed study participation which included 10 subjects in the biopsy subgroup.

Detailed description

This single-center, split-body, double-blind, randomized, controlled clinical trial is being conducted to assess the efficacy and tolerance of the topical firming body moisturizer when used over the course of 12 weeks by women with mild to moderate sagging, crepey skin, and overall photodamage on the upper arms. Efficacy and tolerance will be assessed through clinical grading at baseline and weeks 4, 8, and 12. Efficacy will also be assessed through Corneometer and upper arm circumference measurements at baseline and weeks 4, 8, and 12, and Cutometer and Ultrasound measurements at baseline and weeks 8 and 12. Self-assessment questionnaires will be completed at baseline and week 12. Digital images will be taken at baseline and weeks 4, 8, and 12. Vectra H2 3D images will be taken at baseline and weeks 8 and 12. BMI will be measured at baseline and weeks 8 and 12. Biopsies will be collected from a subgroup of at least 10 subjects at baseline and week 12 (two biopsies on each arm at each time point; total of 8 per biopsy subject). A total of 40 subjects completed study participation which included 10 subjects in the biopsy subgroup.

Conditions

• Photodamaged Skin
• Skin Care

Interventions

Type	Name	Description
OTHER	Topical Body Firming Moisturizer	Moisturizer composed of a patent-pending blend of botanical extracts, bioavailable peptides, antioxidants, and a prebiotic innovation
OTHER	Body Cleanser	Body cleanser to be used by study participants
OTHER	Sunscreen	Sunscreen to be applied after application of moisturizer
OTHER	Placebo Moisturizer	Placebo moisturizer is the vehicle control of the topical body firming moisturizer

Timeline

• Start date: 2018-12-13
• Primary completion: 2019-04-01
• Completion: 2019-07-17
• First posted: 2019-08-22
• Last updated: 2019-08-22

Locations

1 site across 1 country: United States