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

NCT06452667 | Not Yet Recruiting

• 1 other identifier: CPRPG5P0011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Photoaging

Keywords

photoaging; platelet rich plasma; Platelet rich fibrin

Outcome Measures

Primary Outcomes (1)

• Global Aesthetic Improvement Scale

  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 Outcomes (2)

• Fitzpatrick wrinkle scale

  3 months after the last session of treatment

• Wrinkle Severity Rating scale

  3 months after the last session of treatment

Other Outcomes (8)

• The scores of rhytids in VISIA system

  3 months after the last session of treatment

• The scores of Textures in VISIA system

  3 months after the last session of treatment

• The scores of Pores size in VISIA system

  3 months after the last session of treatment

Study Arms (2)

platelet-rich fibin

EXPERIMENTAL

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

platelet-rich palsma

ACTIVE COMPARATOR

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

Interventions

platelet-rich fibin PROCEDURE

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.

platelet-rich fibin

platelet-rich palsma PROCEDURE

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.

platelet-rich palsma

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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) or platelet rich fibrin (PRF) therapy.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, Taiwan

Location

Related Publications (7)

• 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

• Mahmoodabadi RA, Golafshan HA, Pezeshkian F, Shahriarirad R, Namazi MR. Evaluation of the Effect of Platelet-Rich Fibrin Matrix in the Correction of Periorbital Wrinkles: An Experimental Clinical Trial. Dermatol Pract Concept. 2023 Jan 1;13(1):e2023050. doi: 10.5826/dpc.1301a50.

  PMID: 36892335 RESULT

• Hassan H, Quinlan DJ, Ghanem A. Injectable platelet-rich fibrin for facial rejuvenation: A prospective, single-center study. J Cosmet Dermatol. 2020 Dec;19(12):3213-3221. doi: 10.1111/jocd.13692. Epub 2020 Sep 23.

  PMID: 32852873 RESULT

• Isik B, Gurel MS, Erdemir AT, Kesmezacar O. Development of skin aging scale by using dermoscopy. Skin Res Technol. 2013 May;19(2):69-74. doi: 10.1111/srt.12033. Epub 2013 Jan 20.

  PMID: 23331299 RESULT

• Evans AG, Ivanic MG, Botros MA, Pope RW, Halle BR, Glassman GE, Genova R, Al Kassis S. Rejuvenating the periorbital area using platelet-rich plasma: a systematic review and meta-analysis. Arch Dermatol Res. 2021 Nov;313(9):711-727. doi: 10.1007/s00403-020-02173-z. Epub 2021 Jan 12.

  PMID: 33433716 RESULT

• Salminen A, Kaarniranta K, Kauppinen A. Photoaging: UV radiation-induced inflammation and immunosuppression accelerate the aging process in the skin. Inflamm Res. 2022 Aug;71(7-8):817-831. doi: 10.1007/s00011-022-01598-8. Epub 2022 Jun 24.

  PMID: 35748903 RESULT

• Diab NAF, Ibrahim AM, Abdallah AM. Fluid Platelet-Rich Fibrin (PRF) Versus Platelet-Rich Plasma (PRP) in the Treatment of Atrophic Acne Scars: A Comparative Study. Arch Dermatol Res. 2023 Jul;315(5):1249-1255. doi: 10.1007/s00403-022-02511-3. Epub 2022 Dec 15.

  PMID: 36520210 RESULT

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: The randomization numbers will be generated via SAS software version 9.4 by independent blinded personnel outside our research team. We will use the randomization numbers to determine the treatment method for both sides of each case before the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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. The other side of the face was treated with platelet-rich fibin (PRF).

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 11, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: May 31, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)