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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRFM | Experimental | Hemi-face injected with PRFM. PRFM was produced from 9 mL of blood (Healeon Medical, Inc). |
|
| Saline | Placebo Comparator | Hemi-face injected with saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRFM injection | Procedure | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Medical College | Valhalla | New York | 10595 | United States |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline injection | Procedure | 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. |
|
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. |
| D017670 |
| Sodium Compounds |