Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Nasolabial Folds
- Sponsor
- The New York Eye & Ear Infirmary
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •healthy adults
- •aged 25- 75 years
- •with moderate to severe nasolabial folds
Exclusion Criteria
- •allergy to local anesthetics
- •history of bleeding disorder
- •active infection at the treatment site
- •injectable filler in the nasolabial folds within past year
Outcomes
Primary Outcomes
Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment.
Time Frame: Difference in Measurements taken Pre-treatment and 12 weeks after 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.
Secondary Outcomes
- Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week(pre-treatment to 1 week after treatment)
- Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks(Pre-treatment to 2 weeks after treatment)
- Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks(Pre-treatment to 6 weeks after treatment)