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

Study Overview
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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.

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

Conditions
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Nasolabial Folds

Intervention / Treatment
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* Biological: Platelet rich fibrin matrix


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: platelet rich fibrin matrix<br>Both nasolabial folds treated with 0-2 cc of autologous platelet rich fibrin matrix,sufficient to efface nasolabial fold | Biological: Platelet rich fibrin matrix<br>* 0-2 cc of autologous platelet rich fibrin matrix injected intra and subdermally to effect nasolabial fold.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-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. | Difference in Measurements taken Pre-treatment and 12 weeks after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week | 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 | pre-treatment to 1 week after treatment | 
| Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks | 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 | Pre-treatment to 2 weeks after treatment | 
| Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks | 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 | Pre-treatment to 6 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasolabial folds, platelet rich plasma, fibrin matrix, facial rhytids, dermal filler