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

• ClinicalTrials.gov Identifier: NCT03878381
• Recruitment Status: Recruiting
• First Posted: March 18, 2019
• Last Update Posted: November 17, 2021
• Sponsor: Wayne State University
• Information provided by (Responsible Party): Steven D Daveluy, Wayne State University

Study Description

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.

Study Design

• 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
• Actual Study Start Date: April 1, 2019
• Estimated Primary Completion Date: October 1, 2022
• Estimated Study Completion Date: November 1, 2022

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

United States, Michigan

WSUPG Dermatology; Recruiting

Dearborn, Michigan, United States, 48124

Contact: Steven D Daveluy 313-429-7854 sdaveluy@med.wayne.edu

Sponsors and Collaborators

Wayne State University

More Information

Publications:

Halla N, Fernandes IP, Heleno SA, Costa P, Boucherit-Otmani Z, Boucherit K, Rodrigues AE, Ferreira ICFR, Barreiro MF. Cosmetics Preservation: A Review on Present Strategies. Molecules. 2018 Jun 28;23(7). pii: E1571. doi: 10.3390/molecules23071571. Review.

Oba A, Edwards C. Relationships between changes in mechanical properties of the skin, wrinkling, and destruction of dermal collagen fiber bundles caused by photoaging. Skin Res Technol. 2006 Nov;12(4):283-8.

Kulick MI, Gajjar NA. Analysis of histologic and clinical changes associated with Polaris WR treatment of facial wrinkles. Aesthet Surg J. 2007 Jan-Feb;27(1):32-46. doi: 10.1016/j.asj.2006.12.011.

Vasquez-Pinto LM, Maldonado EP, Raele MP, Amaral MM, de Freitas AZ. Optical coherence tomography applied to tests of skin care products in humans--a case study. Skin Res Technol. 2015 Feb;21(1):90-3. doi: 10.1111/srt.12161. Epub 2014 Jul 26.

Hibler BP, Qi Q, Rossi AM. Current state of imaging in dermatology. Semin Cutan Med Surg. 2016 Mar;35(1):2-8. doi: 10.12788/j.sder.2016.001. Review.

• Responsible Party: Steven D Daveluy, Assistant Professor, Wayne State University
• ClinicalTrials.gov Identifier: NCT03878381
• Other Study ID Numbers: 1902002047
• First Posted: March 18, 2019
• Last Update Posted: November 17, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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