Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds

The New York Eye & Ear Infirmary15 enrolled

Overview

Platelets are a component of blood, which contain factors which can enhance wound healing. This study proposes to evaluate the clinical response of laugh lines treated with a concentrated preparation of the subject's own platelets injected into or under the skin by taking serial photographs of the subject's face over a 12 week period. Also, the same preparation will be injected into or under the skin of the arm near the elbows, and serial biopsies will be taken over a 12 week period.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nasolabial Folds

Interventions

Platelet rich fibrin matrixBIOLOGICAL

0-2 cc of autologous platelet rich fibrin matrix injected intra and subdermally to effect nasolabial fold.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy adults * aged 25- 75 years * with moderate to severe nasolabial folds Exclusion Criteria: * pregnant * allergy to local anesthetics * history of bleeding disorder * active infection at the treatment site * injectable filler in the nasolabial folds within past year

Locations (1)

The New York Eye & Ear Infirmary- Otolaryngology Faculty practice satellite

Chappaqua, New York, United States

Outcomes

Primary Outcomes

Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment.

Difference in wrinkle assessment score, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale)between pre-treatment and 12 weeks post-treatment.

Time frame: Difference in Measurements taken Pre-treatment and 12 weeks after treatment.

Secondary Outcomes

Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week

Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 1 week

Time frame: pre-treatment to 1 week after treatment

Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks

Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 2 weeks

Time frame: Pre-treatment to 2 weeks after treatment

Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks

Difference in Wrinkle Assessment Scores, values ranging from 0 (least noticeable) to 5 ( most noticeable) (scores on a scale), between Pre-treatment and 6 Weeks

Time frame: Pre-treatment to 6 weeks after treatment

Data from ClinicalTrials.gov

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