The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation

NCT ID: NCT04128046

Last Updated: 2019-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-03
• Study Completion Date: 2019-06-01

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.

Conditions

Skin Rejuvenation; Skin Quality; Wrinkle; Nasolabial Fold

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PRFM

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

Group Type: EXPERIMENTAL

PRFM injection

Intervention Type: 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.

Saline

Hemi-face injected with saline.

Group Type: PLACEBO_COMPARATOR

Saline injection

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New York Medical College

OTHER

Sponsor Role: lead

Responsible Party

Manoj Abraham

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

New York Medical College

Valhalla, New York, United States

Countries

United States

Other Identifiers

12698

Identifier Type: -

Identifier Source: org_study_id