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

Aging Clinical Trial

Official title:

Chang Gung Memorial Hospital, Taipei, Taiwan

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05096650
• Other study ID #: CMRPG5K0121
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2021
• Source: Chang Gung Memorial Hospital
• Contact: Yau-Li Huang, MD
• Phone: +886-3-3196200
• Email: henryhuang0219[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion criteria:

1. Men or female patients older than 20 years old with facial photoaging (Glogau Scale type II)

2. The photoaging severity of bilateral face is symmetric.

Exclusion criteria:

1. Patients with thrombocytopenia, coagulopathy, hematopoietic malignancy.

2. Patients with severe inflammation over treated area, malignancy, keloid, or poor wound healing history.

3. Patients had received laser, radiofrequency, ultherapy over treated area within 6 months.

4. Patients had received botulism or filler injection over treated area within 12 months.

5. Patients had received plastic surgery over treated area within 12 months.

6. Patients had severe psychiatric disorders with poor control.

7. Patients with other diseases which are not suitable for receiving platelet rich plasma (PRP) injection therapy.

Related Conditions & MeSH terms

• Aging
• Platelet-Rich Plasma

Intervention

Procedure:
• mesotherapy of platelet rich plasma and platelet poor plasma
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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Cameli N, Mariano M, Cordone I, Abril E, Masi S, Foddai ML. Autologous Pure Platelet-Rich Plasma Dermal Injections for Facial Skin Rejuvenation: Clinical, Instrumental, and Flow Cytometry Assessment. Dermatol Surg. 2017 Jun;43(6):826-835. doi: 10.1097/DSS — View Citation

Elnehrawy NY, Ibrahim ZA, Eltoukhy AM, Nagy HM. Assessment of the efficacy and safety of single platelet-rich plasma injection on different types and grades of facial wrinkles. J Cosmet Dermatol. 2017 Mar;16(1):103-111. doi: 10.1111/jocd.12258. Epub 2016 — View Citation

Lee ZH, Sinno S, Poudrier G, Motosko CC, Chiodo M, Saia W, Gothard D, Thomson JE, Hazen A. Platelet rich plasma for photodamaged skin: A pilot study. J Cosmet Dermatol. 2019 Feb;18(1):77-83. doi: 10.1111/jocd.12676. Epub 2018 May 31. — View Citation

Mehryan P, Zartab H, Rajabi A, Pazhoohi N, Firooz A. Assessment of efficacy of platelet-rich plasma (PRP) on infraorbital dark circles and crow's feet wrinkles. J Cosmet Dermatol. 2014 Mar;13(1):72-8. doi: 10.1111/jocd.12072. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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