An interventional study of PRFM injection and Saline injection in Skin Rejuvenation, Skin Quality and Wrinkle, sponsored by New York Medical College. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-22.
Sponsored by New York Medical College · Not applicable, Interventional, and Treatment
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.
New York Medical College is the lead sponsor of 69 studies on the registry; 23 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hemi-face injected with PRFM. PRFM was produced from 9 mL of blood (Healeon Medical, Inc).
Procedure: PRFM injection
Hemi-face injected with saline.
Procedure: Saline injection
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.
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.
Change in VISIA skin score
Difference between pre- and post-treatment VISIA analysis scores for skin parameters of spots, wrinkles, texture, and pores
Time frame: Skin analysis performed at initial visit, at 6 weeks, and at 12 weeks following initial treatment
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
Time frame: 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.
Time frame: 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.
Time frame: Evaluation distributed at initial visit, at 6 weeks, and at 12 weeks following treatment.
Plan to share: No
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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New York Medical College