Clinical trial NCT04065035: A Clinical Study to Evaluate Efficacy and Tolerability of a Cosmetic Product for Arm Firming
Official title: A Double-Blind Split-Body Placebo-Controlled Clinical Study to Evaluate the Efficacy of a Cosmetic Product for Arm Firming
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Photodamaged Skin
Skin Care
Keywords: Body
moisturizer
Firming
Lead sponsor: Revision Skincare
Sponsor class: INDUSTRY
Collaborators: name: Stephens & Associates, Inc.
First posted: 2019-08-22
Enrollment: 46
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split Body, randomized, and placebo controlled
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Skin Crepiness Score
timeFrame: 12 weeks
measure: Change from Baseline in Skin Elasticity Score
timeFrame: 12 weeks
measure: Change from Baseline in Skin Firmness Score
timeFrame: 12 weeks
measure: Change from Baseline in Skin Sagging Score
timeFrame: 12 weeks
measure: Change from Baseline in Skin Roughness (Visual) Score
timeFrame: 12 weeks
measure: Change from Baseline in Skin Roughness (Tactile) Score
timeFrame: 12 weeks
measure: Change from Baseline in Overall Photodamage Score
timeFrame: 12 weeks
measure: Change from Baseline in Evenness of Skin Tone Score
timeFrame: 12 weeks
measure: Change from Baseline in Evenness of Skin Redness Score
timeFrame: 12 weeks
measure: Change from Baseline in Objective Erythema Parameters
timeFrame: 12 weeks
measure: Change from Baseline in Objective Edema Parameters
timeFrame: 12 weeks
measure: Change from Baseline in Objective Dryness Parameters
timeFrame: 12 weeks
measure: Change from Baseline in Objective Peeling Parameters
timeFrame: 12 weeks
measure: Change from Baseline in Subjective Burning Parameters
timeFrame: 12 weeks
measure: Change from Baseline in Subjective Stinging Parameters
timeFrame: 12 weeks
measure: Change from Baseline in Subjective Itching Parameters
timeFrame: 12 weeks
measure: Change from Baseline in Subjective Tingling Parameters
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Richardson
country: United States
facility: Stephens and Associates
state: Texas
Study officials:
affiliation: Thomas J. Stephens & Associates, Inc
name: Lily Jiang, PhD
role: PRINCIPAL_INVESTIGATOR
References: