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

NCT ID: NCT03878381

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2022-10-29

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

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.

Conditions

Skin Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Compounded Skin Care Cream

One side of the face will be randomly chosen as the treatment side

Group Type: EXPERIMENTAL

Skin Care Cream

Intervention Type: COMBINATION_PRODUCT

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

The other side of the face will be randomly chosen as the control

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The placebo will be a formula with no active ingredients

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Placebo

The placebo will be a formula with no active ingredients

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Steven D Daveluy

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

WSUPG Dermatology

Dearborn, Michigan, United States

Countries

United States

References

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):1571. doi: 10.3390/molecules23071571.

Reference Type: BACKGROUND

PMID: 29958439 (View on PubMed)

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. doi: 10.1111/j.0909-752X.2006.00154.x.

Reference Type: BACKGROUND

PMID: 17026660 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19341628 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25066480 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26963110 (View on PubMed)

Other Identifiers

1902002047

Identifier Type: -

Identifier Source: org_study_id