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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-13

Study Completion Date

2019-07-17

Brief Summary

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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.

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Detailed Description

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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

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Photodamaged Skin Skin Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split Body, randomized, and placebo controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Prior to the start of the study, Stephens will generate 2 randomization lists (1 for biopsy subjects and 1 for non-biopsy subjects) to establish treatment assignment to 1 arm (left or right) with the other arm untreated (receiving a placebo). Each list will first be created by concatenating blocks of size of 4 subjects, 2 with left arm treated/right arm untreated and 2 with right arm treated/left arm untreated. The lists will then be randomized by variables from 2 independent uniform distributions: 1 to randomize subjects within block and 1 to randomize blocks. After the randomization lists are created, treatment arm will be assigned to each subject number accordingly.

Study Groups

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Topical Firming Body Moisturizer

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

Group Type ACTIVE_COMPARATOR

Topical Body Firming Moisturizer

Intervention Type OTHER

Moisturizer composed of a patent-pending blend of botanical extracts, bioavailable peptides, antioxidants, and a prebiotic innovation

Body Cleanser

Intervention Type OTHER

Body cleanser to be used by study participants

Sunscreen

Intervention Type OTHER

Sunscreen to be applied after application of moisturizer

Placebo Moisturizer

Oil-in-water emulsion base containing emollients.

Group Type PLACEBO_COMPARATOR

Body Cleanser

Intervention Type OTHER

Body cleanser to be used by study participants

Sunscreen

Intervention Type OTHER

Sunscreen to be applied after application of moisturizer

Placebo Moisturizer

Intervention Type OTHER

Placebo moisturizer is the vehicle control of the topical body firming moisturizer

Interventions

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Topical Body Firming Moisturizer

Moisturizer composed of a patent-pending blend of botanical extracts, bioavailable peptides, antioxidants, and a prebiotic innovation

Intervention Type OTHER

Body Cleanser

Body cleanser to be used by study participants

Intervention Type OTHER

Sunscreen

Sunscreen to be applied after application of moisturizer

Intervention Type OTHER

Placebo Moisturizer

Placebo moisturizer is the vehicle control of the topical body firming moisturizer

Intervention Type OTHER

Other Intervention Names

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Dove Sensitive Skin Nourishing Body Wash Neutrogena® Ultra Sheer® Dry-Touch Sunscreen Broad Spectrum Sunscreen Protection Factor 55

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes