The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation

Study Overview
=================
Brief Summary
-----------------
Platelet-rich fibrin matrix (PRFM) is made from platelets that are extracted from a patient's blood, and many plastic surgeons and dermatologists have used it to fill in wrinkles and lines on the face. Both patients and doctors have observed that it gives extra volume in these areas and improves overall appearance. However, there is no research that shows how PRFM affects skin quality, such as pores, spots, red areas, and texture. The aim of this study is to determine whether PRFM has a role in rejuvenating facial skin.

Official Title
-----------------
The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation: A Split Face Comparison

Conditions
-----------------
Skin Rejuvenation, Skin Quality, Wrinkle, Nasolabial Fold

Intervention / Treatment
-----------------
* Procedure: PRFM injection
* Procedure: Saline injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18 years of age and older who had a dermatological concern, specifically, conspicuous spots, pores, rhytids, uneven texture, or red or brown discoloration, and a VISIA complexion analysis score greater than 10 Agreed to continue any contraceptive hormonal therapy for duration of the study Agreed to not initiate the use of hormonal therapy during the study Agreed to not undergo any facial procedures or treatments, including injections and fillers, lasers, peels, and topical therapies, during the duration of the study Agreed to adhere to a standardized skin care regimen throughout the duration of the study consisting of the use of a single cleanser and moisturizer twice a day Agreed to refrain from excessive sun exposure/tanning Exclusion Criteria: History of skin/connective tissue disorders History of immunosuppressive therapy or radiotherapy Participation in facial procedures, such as injections, lasers, peels, and dermabrasion, in the last six months Use of topical/prescription acne medications in the last three months Current smokers or prior smokers who quit fewer than 10 years ago

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRFM<br>Hemi-face injected with PRFM. PRFM was produced from 9 mL of blood (Healeon Medical, Inc). | Procedure: PRFM injection<br>* Using a 27-gauge microcannula, a total of 4 mL of PRFM was injected intradermally into the mid-cheek and NLF (2 mL for each site) on one side of the face.<br>|
| Placebo Comparator: Saline<br>Hemi-face injected with saline. | Procedure: Saline injection<br>* Using a 27-gauge microcannula, a total of 4 mL of saline was injected intradermally into the mid-cheek and NLF (2 mL for each site) on the contralateral side of the face.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VISIA skin score | Difference between pre- and post-treatment VISIA analysis scores for skin parameters of spots, wrinkles, texture, and pores | Skin analysis performed at initial visit, at 6 weeks, and at 12 weeks following initial treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Wrinkle Severity Rating Scale | Difference between pre- and post-treatment quantitative grading of nasolabial folds for each group. Graded from 1 through 5, with 5 representing the worst score | Rating occurred at initial visit, at 6 weeks, and at 12 weeks following initial treatment | 
| Skin Rejuvenation Outcomes Evaluation (SROE) | Patient-reported outcome measure validated for skin resurfacing techniques. Each item is rated on a 0-4 scale. The final score is computed by dividing the total score for the instrument by 24 and multiplying by 100, giving a range of 0-100. The difference in the change in SROE score for each cohort was calculated. | Evaluation distributed at initial visit, at 6 weeks, and at 12 weeks following treatment. | 
| VISIA Outcomes Questionnaire | Evaluation targeted specifically at identifying changes in the skin parameters analyzed by VISIA. Each item is rated on a 0-4 scale. The final score is computed by dividing the total score for the instrument by 24 and multiplying by 100, giving a range of 0-100. The difference in the change in VISIA outcomes score for each cohort was calculated. | Evaluation distributed at initial visit, at 6 weeks, and at 12 weeks following treatment. |