The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation

NCT04128046 | Completed

• 1 other identifier: 12698
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Wrinkle Severity Rating Scale

  Rating occurred at initial visit, at 6 weeks, and at 12 weeks following initial treatment

• Skin Rejuvenation Outcomes Evaluation (SROE)

  Evaluation distributed at initial visit, at 6 weeks, and at 12 weeks following treatment.

• VISIA Outcomes Questionnaire

  Evaluation distributed at initial visit, at 6 weeks, and at 12 weeks following treatment.

Study Arms (2)

PRFM

EXPERIMENTAL

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

Procedure: PRFM injection

Saline

PLACEBO COMPARATOR

Hemi-face injected with saline.

Procedure: Saline injection

Interventions

PRFM injection 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.

PRFM

Saline injection 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.

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Medical College: lead

Study Sites (1)

New York Medical College

Valhalla, New York, 10595, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: October 16, 2019
• Study Start: September 3, 2018
• Primary Completion: May 28, 2019
• Study Completion: June 1, 2019
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)