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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Chang Gung Memorial Hospital, Taipei, Taiwan

Conditions
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Platelet-Rich Plasma, Aging

Intervention / Treatment
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* Procedure: mesotherapy of platelet rich plasma and platelet poor plasma


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Men or female patients older than 20 years old with facial photoaging (Glogau Scale type II) The photoaging severity of bilateral face is symmetric. Exclusion criteria: Patients with thrombocytopenia, coagulopathy, hematopoietic malignancy. Patients with severe inflammation over treated area, malignancy, keloid, or poor wound healing history. Patients had received laser, radiofrequency, ultherapy over treated area within 6 months. Patients had received botulism or filler injection over treated area within 12 months. Patients had received plastic surgery over treated area within 12 months. Patients had severe psychiatric disorders with poor control. Patients with other diseases which are not suitable for receiving platelet rich plasma (PRP) injection therapy.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind, randomized, split-face
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: platelet rich plasma<br>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. | Procedure: mesotherapy of platelet rich plasma and platelet poor plasma<br>* Each case will receive 3 sessions of injection therapies with one month interval. Each case will receive platelet rich plasma therapy on one side of the face. The other side of the face was treated with platelet poor plasma.<br>|
| Other: platelet poor plasma<br>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. | Procedure: mesotherapy of platelet rich plasma and platelet poor plasma<br>* Each case will receive 3 sessions of injection therapies with one month interval. Each case will receive platelet rich plasma therapy on one side of the face. The other side of the face was treated with platelet poor plasma.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet-Rich Plasma, photoaging, mesotherapy