Platelet Rich Plasma for Treatment of Facial Photoaging: A Double-blind, Randomized, Split-face Study

Not Applicable

• Conditions: Platelet-Rich Plasma; Aging
• Interventions: Procedure: mesotherapy of platelet rich plasma and platelet poor plasma

• Registration Number: NCT05096650
• Lead Sponsor: Chang Gung Memorial Hospital

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 Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-24
• Last Update Submitted: 2021-10-24
• Study First Posted: 2021-10-27
• Last Update Posted: 2021-10-27
• Study Start: 2021-11-30
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
platelet rich plasma	mesotherapy of platelet rich plasma and platelet poor plasma	Each case will receive 3 sessions of injection therapies with one month interval. The practitioner will inject 2ml of platelet rich plasma with fan and linear method into photoaging areas in one side of the midface in one session of treatment.
platelet poor plasma	mesotherapy of platelet rich plasma and platelet poor plasma	Each case will receive 3 sessions of injection therapies with one month interval. The practitioner will inject 2ml of platelet rich plasma with fan and linear method into photoaging areas in the other side of the midface in one session of treatment.

Primary Outcome Measures

Name	Time	Method
Global Aesthetic Improvement Scale	3 months after the last session of treatment	To assess the global aesthetic improvement in appearance compared to pretreatment (minimum: -1, worse; maximum: 3, very much improved)
Fitzpatrick wrinkle scale	3 months after the last session of treatment	To assess the severity of wrinkles of photoaging areas (minimum: 1, mild; maximum: 9, severe)
Wrinkle Severity Rating scale	3 months after the last session of treatment	To assess the severity of wrinkles of photoaging areas (minimum: 1, absent; maximum: 5, extreme)

Secondary Outcome Measures

Name	Time	Method
The scores of texture in VISIA system	before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment	Apply the scores of different aging domains in VISIA system for evaluating the therapeutic response.; (minimum: 1, worse; maximum: 100, severe)
The scores of pores size in VISIA system	before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment	Apply the scores of different aging domains in VISIA system for evaluating the therapeutic response.; (minimum: 1, worse; maximum: 100, severe)
The scores of rhytids in VISIA system	before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment	Apply the scores of different aging domains in VISIA system for evaluating the therapeutic response.; (minimum: 1, worse; maximum: 100, severe)
The scores of brownish spots in VISIA system	before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment	Apply the scores of different aging domains in VISIA system for evaluating the therapeutic response.; (minimum: 1, worse; maximum: 100, severe)
The scores of pigment spots in VISIA system	before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment	Apply the scores of different aging domains in VISIA system for evaluating the therapeutic response.; (minimum: 1, worse; maximum: 100, severe)

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taipei, Taiwan