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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00874094
First received: April 1, 2009
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Nasolabial Folds
Biological: Platelet rich fibrin matrix
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds

Further study details as provided by The New York Eye & Ear Infirmary:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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:
  • Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week [ Time Frame: pre-treatment to 1 week after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Pre-treatment to 2 weeks after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Pre-treatment to 6 weeks after treatment ] [ Designated as safety issue: No ]
    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


Enrollment: 15
Study Start Date: April 2008
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: platelet rich fibrin matrix
Both nasolabial folds treated with 0-2 cc of autologous platelet rich fibrin matrix,sufficient to efface nasolabial fold
Biological: Platelet rich fibrin matrix
0-2 cc of autologous platelet rich fibrin matrix injected intra and subdermally to effect nasolabial fold.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874094

Locations
United States, New York
The New York Eye & Ear Infirmary- Otolaryngology Faculty practice satellite
Chappaqua, New York, United States, 10514
Sponsors and Collaborators
The New York Eye & Ear Infirmary
Investigators
Principal Investigator: Anthony P Sclafani, MD The New York Eye & Ear Infirmary
  More Information

Publications:
Responsible Party: The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier: NCT00874094     History of Changes
Other Study ID Numbers: 08.01
Study First Received: April 1, 2009
Results First Received: July 18, 2011
Last Updated: July 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The New York Eye & Ear Infirmary:
nasolabial folds
platelet rich plasma
fibrin matrix
facial rhytids
dermal filler

ClinicalTrials.gov processed this record on April 17, 2014