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

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.

Study Overview

• Status: Completed
• Conditions: Skin Care; Photodamaged Skin
• Intervention / Treatment: Other: Topical Body Firming Moisturizer; Other: Body Cleanser; Other: Sunscreen; Other: Placebo Moisturizer

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75081
      • Stephens and Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Topical Firming Body Moisturizer; Oil-in-water emulsion base containing emollients, botanical extracts, peptides, antioxidants, prebiotics, and modified theophylline ingredients.	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 Names: Dove Sensitive Skin Nourishing Body Wash; Other: Sunscreen; Sunscreen to be applied after application of moisturizer; Other Names: Neutrogena® Ultra Sheer® Dry-Touch Sunscreen Broad Spectrum Sunscreen Protection Factor 55
Placebo Comparator: Placebo Moisturizer; Oil-in-water emulsion base containing emollients.	Other: Body Cleanser; Body cleanser to be used by study participants; Other Names: Dove Sensitive Skin Nourishing Body Wash; Other: Sunscreen; Sunscreen to be applied after application of moisturizer; Other Names: Neutrogena® Ultra Sheer® Dry-Touch Sunscreen Broad Spectrum Sunscreen Protection Factor 55; Other: Placebo Moisturizer; Placebo moisturizer is the vehicle control of the topical body firming moisturizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Skin Crepiness Score	Investigator assessed the participants' skin crepiness using a 10-point scale where none 0 = skin appears smooth with no crinkling to severe 9 = prominent, extensive crinkly texture at baseline, week 4, 8, and 12. A decrease in score indicates improvement.	12 weeks
Change from Baseline in Skin Elasticity Score	Investigator assessed the participants' skin elasticity using a 10-point scale where none 0 = skin feels toned, dense and resilient to severe 9 = skin feels pliable, thin and nonresilient at baseline, week 8 and 12. A decrease in score indicates improvement.	12 weeks
Change from Baseline in Skin Firmness Score	Investigator assessed the participants' skin firmness using a 10-point scale where none 0 = skin appears very firm and feels thick to severe 9 = loose-appearing skin with poor stretch properties at baseline, week 8 and 12. A decrease in score indicates improvement.	12 weeks
Change from Baseline in Skin Sagging Score	Investigator assessed the participants' skin sagging using a 10-point scale where none 0 = no sagging, upper arm shows tight, lifted appearance to severe 9 = upper arm shows extreme sagging appearance at baseline, week 8 and 12. A decrease in score indicates improvement.	12 weeks
Change from Baseline in Skin Roughness (Visual) Score	Investigator assessed the participants' skin roughness (visual) using a 10-point scale where none 0 = smooth skin appearance, no roughness to severe 9 = pronounced reduction in skin smoothness appearance at baseline, week 4. 8, and 12. A decrease in score indicates improvement.	12 weeks
Change from Baseline in Skin Roughness (Tactile) Score	Investigator assessed the participants' skin roughness (tactile) using a 10-point scale where none 0 = no palpable skin roughness, drag or surface bumps to severe 9 = significantly palpable skin roughness, drag, and surface bumps at baseline, week 4, 8 and 12. A decrease in score indicates improvement.	12 weeks
Change from Baseline in Overall Photodamage Score	Investigator assessed the participants' overall photodamage using a 10-point scale where none 0 = none or minimal visual evidence of photodamaged skin to severe 9 = severe photodamaged skin at baseline, week 8 and 12. A decrease in score indicates improvement.	12 weeks
Change from Baseline in Evenness of Skin Tone Score	Investigator assessed the participants' evenness of skin tone using a 10-point scale where none 0 = even skin color, no observable hyperpigmentation to severe 9 = significant detectable hyperpigmentation appearance at baseline, week 8 and 12. A decrease in score indicates improvement.	12 weeks
Change from Baseline in Evenness of Skin Redness Score	Investigator assessed the participants' evenness of skin redness using a 10-point scale where none 0 = even skin tone to severe 9 = pronounced areas of redness at baseline, week 4, 8, and 12. A decrease in score indicates improvement.	12 weeks
Change from Baseline in Objective Erythema Parameters	Investigator assessed the participants' signs of erythema using a 4-point scale where none 0 = no erythema to severe 4 = marked redness at baseline and week 12. A decrease in score indicates improvement.	12 weeks
Change from Baseline in Objective Edema Parameters	Investigator assessed the participants' signs of edema using a 4-point scale where none 0 = no edema or swelling to severe 4 = marked edema at baseline and week 12. A decrease in score indicates improvement.	12 weeks
Change from Baseline in Objective Dryness Parameters	Investigator assessed the participants' signs of dryness using a 4-point scale where none 0 = no dryness to severe 4 = marked dryness at baseline and week 12. A decrease in score indicates improvement.	12 weeks
Change from Baseline in Objective Peeling Parameters	Investigator assessed the participants' signs of peeling using a 4-point scale where none 0 = no peeling to severe 4 = marked peeling at baseline and week 12. A decrease in score indicates improvement.	12 weeks
Change from Baseline in Subjective Burning Parameters	Participants assessed signs of burning using a 4-point scale where none 0 = no burning to severe 4 = hot burning sensation at baseline and week 12. A decrease in score indicates improvement.	12 weeks
Change from Baseline in Subjective Stinging Parameters	Participants assessed signs of stinging using a 4-point scale where none 0 = no stinging to severe 4 = marked stinging sensation at baseline and week 12. A decrease in score indicates improvement.	12 weeks
Change from Baseline in Subjective Itching Parameters	Participants assessed signs of itching using a 4-point scale where none 0 = no itching to severe 4 = marked itching sensation at baseline and week 12. A decrease in score indicates improvement.	12 weeks
Change from Baseline in Subjective Tingling Parameters	Participants assessed signs of tingling using a 4-point scale where none 0 = no tingling to severe 4 = marked tingling sensation at baseline and week 12. A decrease in score indicates improvement.	12 weeks

Collaborators and Investigators

• Sponsor: Revision Skincare
• Collaborators: Stephens & Associates, Inc.
• Investigators: Principal Investigator: Lily Jiang, PhD, Thomas J. Stephens & Associates, Inc

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2018
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): July 17, 2019

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Body; moisturizer; Firming
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents
• Other Study ID Numbers: C18-D134

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No