The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation

Wrinkle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04128046
• Other study ID #: 12698
• Status: Completed
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: October 2019
• Source: New York Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 1, 2019
• Est. primary completion date: May 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasolabial Fold
• Skin Quality
• Skin Rejuvenation
• Wrinkle

Intervention

Procedure:
• PRFM 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.
• Saline 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.

Locations

Country	Name	City	State
United States	New York Medical College	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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.