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Investigating the Wrinkle Reduction Potential of a Novel Compounded Skin Care Cream

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ClinicalTrials.gov Identifier: NCT03878381
Recruitment Status : Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Steven D Daveluy, Wayne State University

Brief Summary:

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

Detailed Description:
Patients will be advised to discontinue any other products, other than a mild cleanser, prior to beginning treatment. 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. Baseline facial photography and OCT imaging will be performed on both sides of the face. One side of the face will be randomly chosen as the treatment side, and the other as an intrinsic control. Each day, the participant will wash their face in the morning with a standard cleanser, dry their face, then apply the medication to one side of their face and the vehicle to the other side of their face. The patient will then apply a standardized sunscreen SPF 30 to the entire face. Each night, the patient will again wash their face with the standard cleanser, and apply the two medications to the proper sides of the face. Patients will participate in a follow-up clinic visit 4 weeks, 8 weeks, 12 weeks and 16 weeks after beginning treatment. At each visit, photographs and OCT images will be taken of both sides of the face. At week 12, participants will take a survey to determine their satisfaction with the product and their subjective assessment of their skin changes and stop using the products and continue only the sunscreen. Four weeks after cessation of using the creams, they will return for photography and OCT imaging at a final visit.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
Official Title: Investigating the Wrinkle Reduction Potential of a Novel Compounded Skin Care Cream
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : November 1, 2019

Arm Intervention/treatment
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
Drug: Placebo
The placebo will be a formula with no active ingredients




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1. Ages 20 to 60

Exclusion Criteria:

  1. Under age 20
  2. Over age 60
  3. Skin conditions such as rosacea, eczema, and allergic contact dermatitis limited to their face
  4. Allergies to products being tested
  5. Use of a facial anti-aging product within the past 6 weeks

Information from the National Library of Medicine

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


Contacts
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Contact: Steven Daveluy, MD 313-429-7854 sdaveluy@med.wayne.edu

Sponsors and Collaborators
Wayne State University

Publications:
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Responsible Party: Steven D Daveluy, Assistant Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT03878381     History of Changes
Other Study ID Numbers: 1902002047
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No