Status:
COMPLETED
A Clinical Study to Evaluate Efficacy and Tolerability of a Cosmetic Product for Arm Firming
Lead Sponsor:
Revision Skincare
Collaborating Sponsors:
Stephens & Associates, Inc.
Conditions:
Photodamaged Skin
Skin Care
Eligibility:
FEMALE
40-60 years
Phase:
NA
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 o...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2019
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04065035
Start Date
December 13 2018
End Date
July 17 2019
Last Update
August 22 2019
Active Locations (1)
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1
Stephens and Associates
Richardson, Texas, United States, 75081