Investigating the Wrinkle Reduction Potential of a Novel Compounded Skin Care Cream
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|ClinicalTrials.gov Identifier: NCT03878381|
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : November 17, 2021
In the realm of cosmetics, skin care accounts for a significant share accounting for 35.3% of the global market, creating a $121 billion industry. While many of the products claim to have unique, natural formulations that boost skin care, many products contain chemicals that are potentially damaging to skin. Such ingredients include preservatives, parabens, fragrances, and formaldehyde, which can cause skin irritation and inflammation. Although these ingredients help to preserve the stability and longevity of products, it is plausible to achieve efficacy and improve skin structure without risking unnecessary damage.
The condition and health of the dermis rely largely on elastin, which gives the skin its elasticity, and collagen, which provides structure and strength. Collagen deteriorates naturally with age and exposure to environmental elements such as sunlight and toxins. Many skin rejuvenating interventions have focused on preventing the loss of collagen and elastin. The formulations used in this study will try to optimize cellular physiology, which in turn will create improvement in skin function, collagen strength, and wrinkle depth reduction. The skin care regimen we will be testing includes ingredients such Hyaluronic acid 1%, Vitamin E Acetate, Vitamin A Acetate, Co-enzyme Q 10, L-Arginine, L-glutamine, Phytonadione, Argireline Peptide solution, GABA, Vitamin C, glycolic acid, and Fenugreek. The chemicals used commercially have been avoided in this formulation to enhance the beneficial effects of the product.
The purpose of the study is to investigate the efficacy of a new skin care product utilizing the tools of complexion analysis software and optical coherence tomography(OCT). The primary endpoint will be a 15% reduction in facial wrinkles measured by complexion analysis software. Secondary endpoints will be a 10% reduction in skin roughness measured by OCT
|Condition or disease||Intervention/treatment||Phase|
|Skin Care||Combination Product: Skin Care Cream Drug: Placebo||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients will engage in a split face trial, where each participant uses the vehicle on one side of the face and active ingredient treatment cream on the other side|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Block randomization will be utilized to determine which side will be the treatment side.|
|Official Title:||Investigating the Wrinkle Reduction Potential of a Novel Compounded Skin Care Cream|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||October 1, 2022|
|Estimated Study Completion Date :||November 1, 2022|
Experimental: Compounded Skin Care Cream
One side of the face will be randomly chosen as the treatment side
Combination Product: Skin Care Cream
The skin care regimen we will be testing includes ingredients such Hyaluronic acid 1%, Vitamin E Acetate, Vitamin A Acetate, Co-enzyme Q 10, L-Arginine, L-glutamine, Phytonadione, Argireline Peptide solution, GABA, Vitamin C, glycolic acid, and Fenugreek.
Placebo Comparator: Placebo
The other side of the face will be randomly chosen as the control
The placebo will be a formula with no active ingredients
- Reduction in Facial Wrinkle Count [ Time Frame: 16 weeks ]The primary endpoint of this study is a 15% reduction in facial wrinkle count as measured by the Visia complexion analysis software.
- Reduction in Skin Roughness [ Time Frame: 16 weeks ]A secondary endpoint of the study will be a 10% reduction in skin roughness as measured by an OCT image analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878381
|Contact: Steven Daveluy, MDfirstname.lastname@example.org|
|United States, Michigan|
|Dearborn, Michigan, United States, 48124|
|Contact: Steven D Daveluy 313-429-7854 email@example.com|