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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Nasolabial Folds

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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platelet rich fibrin matrix

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

Group Type ACTIVE_COMPARATOR

Platelet rich fibrin matrix

Intervention Type BIOLOGICAL

0-2 cc of autologous platelet rich fibrin matrix injected intra and subdermally to effect nasolabial fold.

Interventions

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Platelet rich fibrin matrix

0-2 cc of autologous platelet rich fibrin matrix injected intra and subdermally to effect nasolabial fold.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes