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临床试验/NCT05734703
NCT05734703招募中早期 1 期

Skin Rejuvenation Using Topical Hemp-based Extract and Other Nutraceuticals

Medical Life Care Planners, LLC1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年3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
招募中
入组人数
25
试验地点
1
主要终点
dermal-epidermal juncton flattening

研究概览

简要总结

Hemp extract has been shown in several pre-clinical and clinical studies to have anti-aging effects on the skin through anti-oxidant and anti-inflammatory effects, in addition resveratrol, thyme and caffeine have been shown to have anti-aging effects related to fibrillar collagen production and extracellular matrix production in the dermis.

A combination of these four ingredients will be used in a vehicle of fermented medium chain triglyceride oil and skin shave biopsies will be taken before and after 90 days use of the topical to look for objective evidence of anti-aging effects in the dermis and epidermis.

详细描述

The study is a case series of 25 adults over age 50 identified through social media outreach in the Tampa Bay area. Each subject will be given a topical serum and advised to apply it once daily to the specific two by two inch area of skin under study (forearm or back of the neck). The serum will be comprised of hemp-extract, resveratrol, caffeine, thyme oil and fermented medium chain triglyceride as a vehicle. The skin anti-aging serum is expected to contain hemp-extract 5%, caffeine 2%, Thyme essential oil 2% and resveratrol 0.5%. The subjects will use the test formulation for 90 days. The subjects will jhave shaved skin biopsies taken on either the forearm or back of the neck. The biopsies will be done on day zero and on day 90.

None of the subjects are currently using anti-aging therapies. No other anti-aging therapy will be used during the 90 days of the research.

The subjects will be advised to apply a thin layer of the serum once each night at bedtime. To the area of skin under study (forearm or back of the neck). The one-ounce bottle of serum is expected to last for the entire 90 days of the study. The subjects will be reminded each day via text messaging to use the product and each subject will be required to text back that the daily treatment has been applied.

The 'before and after' shaved biopsies will be independently evaluated by Dr. Michael Morgan, board certified Dermatopathologist at KorPath, Inc. He will perform hematoxylin and eosin (H&E) staining, for histological analysis for morphology of the dermis and epidermis and histochemical staining for collagen and matrix analysis.

The subjects will be independently clinically evaluated by Dr. Kathy Anderson, board certified Dermatologist. She will determine "before and after" skin wrinkling scores using standard recognized metrics.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 50 or over
  • Glogau Wrinkle Severity Scale of either 3 or 4 on the area to be biopsied.
  • Not on current anti-aging therapies used as an ingredient in the study topical.

排除标准

  • Under age 50
  • Glogau Wrinkle Severity Scale of either 1 or 2 on the area to be biopsied.
  • Currently using anti-aging therapies used as an ingredient in the study topical.
  • Contraindication to performing skin shave biopsies in the area to be biopsied.

研究组 & 干预措施

Standard Topical Daily Dose

Experimental

Only one arm in the study. Subjects treated with the topical daily for 90 days. The comparison will be 'before' and 'after' treatment skin biopsy results.

干预措施: Nutraceutical Topical (Drug)

结局指标

主要结局

dermal-epidermal juncton flattening

时间窗: 90 days

Histologic appearance of dermal-epidermal flattening on 'before' and 'after' skin biopsies.

elastic fiber attenuation

时间窗: 90 days

Histologic appearance of elastic fiber attenuation in the dermis on 'before' and 'after' skin biopsies.

denisty of collagen fiber network

时间窗: 90 days

Histologic appearance of the density of the collagen fibers on 'before' and 'after' skin biopsies.

次要结局

  • Modified Fitzpatrick Wrinkle Scale(90 days)
  • Glogau System: Wrinkle Severity Ranking(90 days)

研究者

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

Gregory L Smith, MD, MPH

Principal Investigaor

Medical Life Care Planners, LLC

研究点 (1)

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