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A Double-Blind Split-Body Placebo-Controlled Clinical Study to Evaluate the Efficacy of a Cosmetic Product for Arm Firming
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.
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.
Age
40 - 60 years
Sex
FEMALE
Healthy Volunteers
Yes
Stephens and Associates
Richardson, Texas, United States
Start Date
December 13, 2018
Primary Completion Date
April 1, 2019
Completion Date
July 17, 2019
Last Updated
August 22, 2019
46
ACTUAL participants
Topical Body Firming Moisturizer
OTHER
Body Cleanser
OTHER
Sunscreen
OTHER
Placebo Moisturizer
OTHER
Lead Sponsor
Revision Skincare
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03963102