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

NCT ID: NCT05096650

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-08-31

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.

Conditions

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Platelet-Rich Plasma Aging

Keywords

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Platelet-Rich Plasma photoaging mesotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind, randomized, split-face
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
1. The participants will blinded to receive platelet rich plasma and platelet poor plasma injections for treatment of photoaging of right side or left side of face.
2. The practitioner will inject these blood products into photoaging areas in bilateral face in each case without the knowledge of the content of injection materials.
3. The outcomes assessors will evaluate the response of the therapies without the knowledge of which blood products injected into bilateral face.

Study Groups

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platelet rich 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.

Group Type EXPERIMENTAL

mesotherapy of platelet rich plasma and platelet poor plasma

Intervention Type PROCEDURE

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.

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.

Group Type OTHER

mesotherapy of platelet rich plasma and platelet poor plasma

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yau-Li Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital, Taipei, Taiwan

Locations

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Chang Gung Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Yau-Li Huang, MD

Role: CONTACT

Phone: +886-3-3196200

Email: [email protected]

Facility Contacts

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Yau-Li Huang, MD

Role: primary

References

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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.

Reference Type RESULT
PMID: 29855132 (View on PubMed)

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.

Reference Type RESULT
PMID: 28375975 (View on PubMed)

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.

Reference Type RESULT
PMID: 27474688 (View on PubMed)

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.

Reference Type RESULT
PMID: 24641609 (View on PubMed)

Other Identifiers

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CMRPG5K0121

Identifier Type: -

Identifier Source: org_study_id