Platelet Rich Fibrin Versus Platelet Rich Plasma for Microneedling Treatment of Facial Photoaging

June 5, 2024 updated by: Yau-Li Huang, Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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) or platelet rich fibrin (PRF) therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: platelet-rich fibin
Each case will receive 3 sessions of therapies with one month interval. We will apply 1-2ml PRF to the photoaging areas in one side of the cheek of patients by using microneedling.
Procedure: platelet-rich fibin
Each case will receive 3 sessions of microneedling therapies with one month interval. Each case will receive platelet-rich fibin therapy on one side of the face. The other side of the face was treated with platelet-rich palsma.
Active Comparator: platelet-rich palsma
Each case will receive 3 sessions of therapies with one month interval. We will apply 1-2ml PRP to the photoaging areas in one side of the cheek of patients by using microneedling.
Procedure: platelet-rich palsma
Each case will receive 3 sessions of microneedling therapies with one month interval. Each case will receive platelet-rich palsma therapy on one side of the face. The other side of the face was treated with platelet-rich fibin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after the last session of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fitzpatrick wrinkle scale
Time Frame: 3 months after the last session of treatment
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
Time Frame: 3 months after the last session of treatment
To assess the severity of wrinkles of photoaging areas (minimum: 1, absent; maximum: 5, extreme)
3 months after the last session of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The scores of rhytids in VISIA system
Time Frame: 3 months after the last session of treatment
Apply the scores of different aging domains in VISIA system for evaluating the therapeutic response. (minimum: 1, worse; maximum: 100, severe)
3 months after the last session of treatment
The scores of Textures in VISIA system
Time Frame: 3 months after the last session of treatment
Apply the scores of different aging domains in VISIA system for evaluating the therapeutic response. (minimum: 1, worse; maximum: 100, severe)
3 months after the last session of treatment
The scores of Pores size in VISIA system
Time Frame: 3 months after the last session of treatment
Apply the scores of different aging domains in VISIA system for evaluating the therapeutic response. (minimum: 1, worse; maximum: 100, severe)
3 months after the last session of treatment
The scores of Brown spots in VISIA system
Time Frame: 3 months after the last session of treatment
Apply the scores of different aging domains in VISIA system for evaluating the therapeutic response. (minimum: 1, worse; maximum: 100, severe)
3 months after the last session of treatment
The scores of Spots in VISIA system
Time Frame: 3 months after the last session of treatment
Apply the scores of different aging domains in VISIA system for evaluating the therapeutic response. (minimum: 1, worse; maximum: 100, severe)
3 months after the last session of treatment
The scores of UV spots in VISIA system
Time Frame: 3 months after the last session of treatment
Apply the scores of different aging domains in VISIA system for evaluating the therapeutic response. (minimum: 1, worse; maximum: 100, severe)
3 months after the last session of treatment
The scores of red areas in VISIA system
Time Frame: 3 months after the last session of treatment
Apply the scores of different aging domains in VISIA system for evaluating the therapeutic response. (minimum: 1, worse; maximum: 100, severe)
3 months after the last session of treatment
Dermoscopy Photoaging Scale
Time Frame: 3 months after the last session of treatment
Photoaging evaluation instrument using a dermoscopy (minimum: 0, worse; maximum: 11, severe)
3 months after the last session of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPRPG5P0011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will not share IPD due to the privacy of participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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