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临床试验/NCT03878381
NCT03878381已完成早期 1 期

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

Wayne State University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
10
试验地点
1
主要终点
Reduction in Facial Wrinkle Count

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Block randomization will be utilized to determine which side will be the treatment side.

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 20 to 60

排除标准

  • 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

研究组 & 干预措施

Compounded Skin Care Cream

Experimental

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

干预措施: Skin Care Cream (Combination Product)

Placebo

Placebo Comparator

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

干预措施: Placebo (Drug)

结局指标

主要结局

Reduction in Facial Wrinkle Count

时间窗: 16 weeks

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

次要结局

  • Reduction in Skin Roughness(16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven D Daveluy

Assistant Professor

Wayne State University

研究点 (1)

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