Nasolabial Fold, Skin Quality, Skin Rejuvenation, Wrinkle
Conditions
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.
Interventions
PROCEDUREPRFM 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.
PROCEDURESaline injection
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.
Sponsors
New York Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VISIA skin score | Skin analysis performed at initial visit, at 6 weeks, and at 12 weeks following initial treatment | Difference between pre- and post-treatment VISIA analysis scores for skin parameters of spots, wrinkles, texture, and pores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wrinkle Severity Rating Scale | Rating occurred at initial visit, at 6 weeks, and at 12 weeks following initial treatment | 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 |
| Skin Rejuvenation Outcomes Evaluation (SROE) | Evaluation distributed at initial visit, at 6 weeks, and at 12 weeks following treatment. | 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. |
| VISIA Outcomes Questionnaire | Evaluation distributed at initial visit, at 6 weeks, and at 12 weeks following treatment. | 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. |
Countries
United States
Outcome results
None listed