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

Phase 1

Completed

• Conditions: Nasolabial Folds
• Interventions: Biological: Platelet rich fibrin matrix

• Registration Number: NCT00874094
• Lead Sponsor: The New York Eye & Ear Infirmary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-01
• Study First Posted: 2009-04-02
• Primary Completion: 2009-06
• Study Completion: 2009-07
• Results First Submitted: 2011-07-18
• Status Verified: 2013-07
• Results First Submitted QC: 2013-07-10
• Last Update Submitted: 2013-07-10
• Results First Posted: 2013-07-12
• Last Update Posted: 2013-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment.	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 Outcome Measures

Name	Time	Method
Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week	pre-treatment to 1 week after treatment	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
Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks	Pre-treatment to 2 weeks after treatment	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
Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks	Pre-treatment to 6 weeks after treatment	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

Trial Locations

Locations (1)

The New York Eye & Ear Infirmary- Otolaryngology Faculty practice satellite; 🇺🇸 Chappaqua, New York, United States