Clinical trial NCT06452667: Platelet Rich Fibrin Versus Platelet Rich Plasma for Microneedling Treatment of Facial Photoaging
Official title: Platelet Rich Fibrin Versus Platelet Rich Plasma for Microneedling Treatment of Facial Photoaging-a Double Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Photoaging
Keywords: photoaging
platelet rich plasma
Platelet rich fibrin
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Global Aesthetic Improvement Scale
timeFrame: 3 months after the last session of treatment
Secondary outcomes:
measure: Fitzpatrick wrinkle scale
timeFrame: 3 months after the last session of treatment
measure: Wrinkle Severity Rating scale
timeFrame: 3 months after the last session of treatment
Other outcomes:
measure: The scores of rhytids in VISIA system
timeFrame: 3 months after the last session of treatment
measure: The scores of Textures in VISIA system
timeFrame: 3 months after the last session of treatment
measure: The scores of Pores size in VISIA system
timeFrame: 3 months after the last session of treatment
measure: The scores of Brown spots in VISIA system
timeFrame: 3 months after the last session of treatment
measure: The scores of Spots in VISIA system
timeFrame: 3 months after the last session of treatment
measure: The scores of UV spots in VISIA system
timeFrame: 3 months after the last session of treatment
measure: The scores of red areas in VISIA system
timeFrame: 3 months after the last session of treatment
measure: Dermoscopy Photoaging Scale
timeFrame: 3 months after the last session of treatment
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
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.
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. doi: 10.5826/dpc.1301a50.
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.
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.
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/s00403-020-02173-z. Epub 2021 Jan 12.
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.
citation: 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.