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Clinical Trials/NCT06452667
NCT06452667
Not yet recruiting
Not Applicable

Platelet Rich Fibrin Versus Platelet Rich Plasma for Microneedling Treatment of Facial Photoaging-a Double Blind Randomized Controlled Study

Chang Gung Memorial Hospital1 site in 1 country30 target enrollmentJune 1, 2024
ConditionsPhotoaging

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Photoaging
Sponsor
Chang Gung Memorial Hospital
Enrollment
30
Locations
1
Primary Endpoint
Global Aesthetic Improvement Scale
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

The present study was conducted for analyzing the efficacy and safety of platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) in photoaging therapy.

Specific arms:

  1. The investigators will compare the photoaging improvement of PRF and PRP treated face before and after treatment by two blinded investigators.
  2. The investigators will evaluate the improvement of each parameter of photoaging by Visia system, dermoscope, and optical coherence tomography.
  3. The investigators will evaluate the safety of the treatment of PRF and PRP.

Each case will receive 3 sessions of injection therapies with one month interval (T0, T1, and T2). Each case will receive PRP therapy on one side of the face and PRF on the other side of face. The investigators will determine the treatment method for both sides of each case randomly by coin flapping before the study. The investigators will evaluate each case before each session of therapy (T0, T1, T2) as well as 1 (T3) and 3 months (T4) after final session of treatment.

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
May 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yau-Li Huang

Principal Investigator

Chang Gung Memorial Hospital

Eligibility Criteria

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) or platelet rich fibrin (PRF) therapy.

Outcomes

Primary Outcomes

Global Aesthetic Improvement Scale

Time Frame: 3 months after the last session of treatment

We will compare the photoaging improvement of PRF and PRP treated face before treatment and 3 months after last treatment by two blinded investigators using Global Aesthetic Improvement Scale (GAIS). GAIS, which is a 5-point scale wherein 5 = very much improved, 4 = much improved, 3 = improved, 2 = no change, and 1= worse.

Secondary Outcomes

  • Wrinkle Severity Rating scale(3 months after the last session of treatment)
  • Fitzpatrick wrinkle scale(3 months after the last session of treatment)

Study Sites (1)

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