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Completed

NCT Number: NCT04128046

The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation

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.

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Key information

Conditions

Skin Rejuvenation Nasolabial Fold Skin Quality Wrinkle

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Medical College

Valhalla, New York, 10595, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in VISIA skin score

    Time frame: 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 outcomes

  1. Change in Wrinkle Severity Rating Scale

    Time frame: 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

  2. Skin Rejuvenation Outcomes Evaluation (SROE)

    Time frame: 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.

  3. VISIA Outcomes Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

New York Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 16, 2019
Registry last updated
Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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