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临床试验/NCT02303496
NCT02303496Unknown1 期

The Effects of Autologous Platelet-Rich Plasma Cream on Photoaging and Chronological Skin Aging

Acibadem University4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年12月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
20
试验地点
4
主要终点
Global efficacy evaluations and quantitative analyzes.

研究概览

简要总结

Human skin undergoes some morphological changes with the effects of chronological aging and photoaging, these are especially remarkable in the facial skin. Changes in pigmentation, sallowness, deep wrinkling, laxity and elastosis are the main changes seen in photoaging and chronologic aging of skin. With the increasing demand, it needs to provide new approach for the prevention and treatment of these morphological changes.

Fibroblasts have a key role on skin aging. It is known that platelet rich plasma activates the fibroblasts and increases the synthesis of collagen and other type of matrix components. Because of these specialities, platelet rich plasma is thought to be effective on skin aging.

详细描述

Clinical evaluation of the patients will be done for five times during 3 months. 0th day (Basal), 7th day, 15th day, 45th day and 105th day.

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
Double (Participant, Care Provider)

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • The patient has periorbital wrinkles with Glogau Scale 3 or more

排除标准

  • Patients with precancerous lesions
  • Patients with inflammatory skin disease like rosacea, psoriasis, seborrheic eczema
  • Patients with connective tissue disease like lupus erythematosus
  • Patients have a cosmetic intervention to their face, like chemical peel, infrared, radio frequency, laser, fillers or botulinum toxin injections in last 6 months
  • Patients who use an anti aging cream containing retinoic acid, vitamin C and peptides in last 3 months
  • Pregnant or lactating females

结局指标

主要结局

Global efficacy evaluations and quantitative analyzes.

时间窗: T4 (105th day)

Evaluation of deep and fine wrinkling, amount of pigmentation, amount of vascularization, clarity of skin assessment done by the patient and the investigator. Quantitative analyzes: Measurements of Antera and Cutometer.

次要结局

  • Number of Participants with Adverse Events and Type of Adverse Effects.(T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day))
  • Deep and fine wrinkling,(T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day))
  • Amount of vascularization(T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day))
  • Clarity of skin(T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day))
  • Smell and texture of cream(T4 (105th day))
  • Changes from baseline and placebo group.(T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day))
  • Amount of pigmentation(T0 (basal condition),T1 (7th day), T2 (15th day), T3 (45th day,) T4 (105th day))

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ercument Ovali

Specialist, Haematology

Acibadem University

研究点 (4)

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