Clinical trial NCT05096650: Platelet Rich Plasma for Treatment of Facial Photoaging: A Double-blind, Randomized, Split-face Study
Official title: Chang Gung Memorial Hospital, Taipei, Taiwan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Platelet-Rich Plasma
Aging
Keywords: Platelet-Rich Plasma
photoaging
mesotherapy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, randomized, split-face
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Global Aesthetic Improvement Scale
timeFrame: 3 months after the last session of treatment
measure: Fitzpatrick wrinkle scale
timeFrame: 3 months after the last session of treatment
measure: Wrinkle Severity Rating scale
timeFrame: 3 months after the last session of treatment
Secondary outcomes:
measure: The scores of rhytids in VISIA system
timeFrame: before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment
measure: The scores of texture in VISIA system
timeFrame: before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment
measure: The scores of pores size in VISIA system
timeFrame: before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment
measure: The scores of pigment spots in VISIA system
timeFrame: before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment
measure: The scores of brownish spots in VISIA system
timeFrame: before the 1st, 2nd and 3rd sessions of treatment as well as 1 and 3 months after the last session of treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital, Taipei, Taiwan
name: Yau-Li Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.0000000000001083.
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 Jul 29.
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.