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

Not Applicable

Not yet recruiting

• Conditions: Photoaging
• Interventions: Procedure: platelet-rich palsma; Procedure: platelet-rich fibin

• Registration Number: NCT06452667
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-30
• Status Verified: 2024-06
• Study Start: 2024-06-01
• Study First Submitted QC: 2024-06-05
• Last Update Submitted: 2024-06-05
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Primary Completion: 2024-12-01
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
platelet-rich palsma	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.
platelet-rich fibin	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.

Primary Outcome Measures

Name	Time	Method
Global Aesthetic Improvement Scale	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 Outcome Measures

Name	Time	Method
Wrinkle Severity Rating scale	3 months after the last session of treatment	To assess the severity of wrinkles of photoaging areas (minimum: 1, absent; maximum: 5, extreme)
Fitzpatrick wrinkle scale	3 months after the last session of treatment	To assess the severity of wrinkles of photoaging areas (minimum: 1, mild; maximum: 9, severe)

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taipei, Taiwan