Photoaging
Conditions
Keywords
photoaging, platelet rich plasma, Platelet rich fibrin
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.
Interventions
PROCEDUREplatelet-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.
PROCEDUREplatelet-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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
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).
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| The scores of Brown spots in VISIA system | 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) |
| The scores of Spots in VISIA system | 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) |
| The scores of rhytids in VISIA system | 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) |
| The scores of red areas in VISIA system | 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) |
| Dermoscopy Photoaging Scale | 3 months after the last session of treatment | Photoaging evaluation instrument using a dermoscopy (minimum: 0, worse; maximum: 11, severe) |
| The scores of UV spots in VISIA system | 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) |
| The scores of Textures in VISIA system | 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) |
| The scores of Pores size in VISIA system | 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) |
Countries
Taiwan
Contacts
Primary ContactYau-Li Huang, MD
Outcome results
None listed