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

NCT05096650 | Unknown

• 1 other identifier: CMRPG5K0121
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet-Rich Plasma; Aging

Keywords

Platelet-Rich Plasma; photoaging; mesotherapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

platelet rich plasma

EXPERIMENTAL

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

platelet poor plasma

OTHER

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

Interventions

mesotherapy of platelet rich plasma and platelet poor plasma 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; platelet rich plasma

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or female patients older than 20 years old with facial photoaging (Glogau Scale type II)
• The photoaging severity of bilateral face is symmetric.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, 105, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 29855132 RESULT

• 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.

  PMID: 28375975 RESULT

• 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.

  PMID: 27474688 RESULT

• 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.

  PMID: 24641609 RESULT

Study Officials

• Yau-Li Huang, MD

  Chang Gung Memorial Hospital, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yau-Li Huang, MD

CONTACT

+886-3-3196200; henryhuang0219@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, split-face

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 27, 2021
• Study Start: November 30, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: October 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)