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

Photoaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452667
• Other study ID #: CPRPG5P0011
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2024
• Source: Chang Gung Memorial Hospital
• Contact: Yau-Li Huang, MD
• Phone: +886-3-3196200
• Email: henryhuang0219[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 31, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Photoaging
• Skin Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

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 De — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. d — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The scores of rhytids in VISIA system	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
Other	The scores of Textures in VISIA system	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
Other	The scores of Pores size in VISIA system	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
Other	The scores of Brown spots in VISIA system	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
Other	The scores of Spots in VISIA system	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
Other	The scores of UV spots in VISIA system	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
Other	The scores of red areas in VISIA system	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
Other	Dermoscopy Photoaging Scale	Photoaging evaluation instrument using a dermoscopy (minimum: 0, worse; maximum: 11, severe)	3 months after the last session of treatment
Primary	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	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
Secondary	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