Viewing Study NCT05096650


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Study NCT ID: NCT05096650
Status: UNKNOWN
Last Update Posted: 2021-10-27
First Post: 2021-10-01
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Platelet Rich Plasma for Treatment of Facial Photoaging: A Double-blind, Randomized, Split-face Study
Sponsor: Chang Gung Memorial Hospital
Organization:

Study Overview

Official Title: Chang Gung Memorial Hospital, Taipei, Taiwan
Status: UNKNOWN
Status Verified Date: 2021-09
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Photoaging is characterized by cellular changes and alterations in dermal extracellular matrix proteins with degeneration of connective tissue caused by intrinsic and extrinsic factors. The clinical manifestations of photoaging included wrinkles, pigmented changes, tissue loss, and sagging. Autologous platelet-rich plasma is a preparation of platelets in concentrated plasma from peripheral blood. The α granules of platelets contained many growth factors. According to previous literature, growth factors in platelet-rich plasma directly stimulate fibroblast proliferation to boost collagen production. It has also been shown to modulate extracellular matrix metabolism and remodeling by increasing the expression of specific matrix metalloproteinases. In review of previous literatures, there was only limited researches of platelet-rich plasma for treatment of photoaging. Therefore, the present study was conducted for analyzing the efficacy and safety of autologous platelet-rich plasma in photoaging therapy.
Detailed Description: Autologous platelet-rich plasma is a preparation of platelets in concentrated plasma from peripheral blood. The α granules of platelets contained many growth factors, such as platelet-derived growth factor, transforming growth factor, vascular endothelial growth factor, and epithelial growth factor. These growth factors can trigger intracellular signaling cascades that ultimately alter gene expression and protein synthesis. Clinically, autologous platelet-rich plasma has been applied for treatment of hair loss, chronic wounds, and atrophic scars.

Photoaging is characterized by cellular changes and alterations in dermal extracellular matrix proteins with degeneration of connective tissue caused by intrinsic and extrinsic factors. The clinical manifestations of photoaging included wrinkles, pigmented changes, tissue loss, and sagging. The therapeutic modalities of photoaging included energy-based device, filler injection, and surgical treatment. However, there are some limitations and drawbacks of these therapies. For example, filler injection may cause foreign body granuloma, vascular occlusions, or tissue necrosis. Surgical treatment is an invasive procedure which may cause hematoma, infection, or scar formation.

According to previous literature, growth factors in platelet-rich plasma directly stimulate fibroblast proliferation to boost collagen production. It has also been shown to modulate extracellular matrix metabolism and remodeling by increasing the expression of specific matrix metalloproteinases. Platelet-rich plasma-enhanced expression of matrix metalloproteinases -1 and -3 helps clear photodamaged extracellular matrix components and allow for a better quality, more organized collagen meshwork. This process helps soften fine lines and minimize scarring. In addition, transforming growth factor and epithelial growth factor in platelet-rich plasma are known to modulate keratinocyte propagation and migration as well as repair barrier function. In review of previous literatures, there was only limited researches of platelet-rich plasma for treatment of photoaging. Therefore, the present study was conducted for analyzing the efficacy and safety of autologous platelet-rich plasma in photoaging therapy.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: