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Trial record 17 of 21 for:    fenugreek

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 : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Steven D Daveluy, Wayne State University

Tracking Information
First Submitted Date  ICMJE March 14, 2019
First Posted Date  ICMJE March 18, 2019
Last Update Posted Date April 25, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03878381 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigating the Wrinkle Reduction Potential of a Novel Compounded Skin Care Cream
Official Title  ICMJE Investigating the Wrinkle Reduction Potential of a Novel Compounded Skin Care Cream
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE 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
Condition  ICMJE Skin Care
Intervention  ICMJE
  • 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.
  • Drug: Placebo
    The placebo will be a formula with no active ingredients
Study Arms  ICMJE
  • Experimental: Compounded Skin Care Cream
    One side of the face will be randomly chosen as the treatment side
    Intervention: Combination Product: Skin Care Cream
  • Placebo Comparator: Placebo
    The other side of the face will be randomly chosen as the control
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Steven Daveluy, MD 313-429-7854 sdaveluy@med.wayne.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03878381
Other Study ID Numbers  ICMJE 1902002047
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Steven D Daveluy, Wayne State University
Study Sponsor  ICMJE Wayne State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Wayne State University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP