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

The New York Eye & Ear Infirmary

Status and phase: Completed; Phase 2; Phase 1

Conditions: Nasolabial Folds

Treatments: Biological: Platelet rich fibrin matrix

Study type: Interventional

Funder types: Other

Identifiers

NCT00874094

08.01

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Female

Ages: 25 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

platelet rich fibrin matrix

Active Comparator group

Description:

Both nasolabial folds treated with 0-2 cc of autologous platelet rich fibrin matrix,sufficient to efface nasolabial fold

Treatment:

Biological: Platelet rich fibrin matrix