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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00874094
Recruitment Status : Completed
First Posted : April 2, 2009
Results First Posted : July 12, 2013
Last Update Posted : July 12, 2013
Sponsor:
Information provided by (Responsible Party):
The New York Eye & Ear Infirmary

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nasolabial Folds Biological: Platelet rich fibrin matrix Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds
Study Start Date : April 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : July 2009
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week [ Time Frame: 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

  2. Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks [ Time Frame: 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

  3. Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874094


Locations
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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
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Principal Investigator: Anthony P Sclafani, MD The New York Eye & Ear Infirmary
More Information
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Publications of Results:

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Responsible Party: The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier: NCT00874094    
Other Study ID Numbers: 08.01
First Posted: April 2, 2009    Key Record Dates
Results First Posted: July 12, 2013
Last Update Posted: July 12, 2013
Last Verified: July 2013
Keywords provided by The New York Eye & Ear Infirmary:
nasolabial folds
platelet rich plasma
fibrin matrix
facial rhytids
dermal filler