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

NCT03878381 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 1902002047
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Skin Care

Outcome Measures

Primary Outcomes (1)

• Reduction in Facial Wrinkle Count

  The primary endpoint of this study is a 15% reduction in facial wrinkle count as measured by the Visia complexion analysis software.

  16 weeks

Secondary Outcomes (1)

• Reduction in Skin Roughness

  16 weeks

Study Arms (2)

Compounded Skin Care Cream

EXPERIMENTAL

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

Combination Product: Skin Care Cream

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Skin Care Cream 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.

Compounded Skin Care Cream

Placebo DRUG

The placebo will be a formula with no active ingredients

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Ages 20 to 60

You may not qualify if:

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

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

WSUPG Dermatology

Dearborn, Michigan, 48124, United States

Location

Related Publications (5)

• 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.

  PMID: 29958439 BACKGROUND

• 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.

  PMID: 17026660 BACKGROUND

• 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.

  PMID: 19341628 BACKGROUND

• 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.

  PMID: 25066480 BACKGROUND

• 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.

  PMID: 26963110 BACKGROUND

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Block randomization will be utilized to determine which side will be the treatment side.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: April 1, 2019
• Primary Completion: October 29, 2022
• Study Completion: October 29, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)