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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04128046
Other study ID # 12698
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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