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

Revision Skincare

Status: Completed

Conditions: Photodamaged Skin; Skin Care

Treatments: Other: Body Cleanser; Other: Placebo Moisturizer; Other: Sunscreen; Other: Topical Body Firming Moisturizer

Study type: Interventional

Funder types: Industry

Identifiers

NCT04065035

C18-D134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age range between 40 and 60 years
• Mild to moderate skin crepiness upper arm region
• Mild to moderate sagging skin upper arm region
• Mild to moderate overall photodamage upper arm region
• Willing to maintain their body weight within +/- 6.5 pounds

Exclusion criteria

• Diagnosed with known allergies to skin care products
• Who have had massive weight loss
• Who have undergone liposuction and/or weight loss surgery in the last 5 years.
• Who are nursing
• Who are pregnant
• History of skin cancer within the past 5 years.
• Having a health condition
• Having a history of immunosuppression/immune deficiency disorders
• Currently using oral or systemic immunosuppressive medications and biologics
• Currently using or having regularly used corticosteroids
• Having a disease such as asthma
• Having started a long-term medication within the last 2 months.
• Who started hormone replacement therapies (HRT)
• Having had brachioplasty (upper arm lift);
• Having liposuction
• Having cryolipolysis
• Having undergone a weight-loss diet or exercise habit change in the last 3 months or planning to start either during the study.
• Having used any of the indicated products or had any of the listed procedures on the upper arms within the indicated time frame prior to the study start date.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

Topical Firming Body Moisturizer

Active Comparator group

Description:

Oil-in-water emulsion base containing emollients, botanical extracts, peptides, antioxidants, prebiotics, and modified theophylline ingredients.

Treatment:

Other: Sunscreen

Other: Topical Body Firming Moisturizer

Other: Body Cleanser

Placebo Moisturizer

Placebo Comparator group

Description:

Oil-in-water emulsion base containing emollients.

Treatment:

Other: Placebo Moisturizer

Other: Sunscreen

Other: Body Cleanser