The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation

New York Medical College

Status: Completed

Conditions: Skin Quality; Skin Rejuvenation; Nasolabial Fold; Wrinkle

Treatments: Procedure: Saline injection; Procedure: PRFM injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04128046

12698

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

PRFM

Experimental group

Description:

Hemi-face injected with PRFM. PRFM was produced from 9 mL of blood (Healeon Medical, Inc).

Treatment:

Procedure: PRFM injection

Saline

Placebo Comparator group

Description:

Hemi-face injected with saline.

Treatment:

Procedure: Saline injection