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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 20, 2014