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

Nasolabial Folds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874094
• Other study ID #: 08.01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 1, 2009
• Last updated: July 10, 2013
• Start date: April 2008
• Est. completion date: July 2009

Study information

• Verified date: July 2013
• Source: The New York Eye & Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasolabial Folds

Intervention

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

Locations

Country	Name	City	State
United States	The New York Eye & Ear Infirmary- Otolaryngology Faculty practice satellite	Chappaqua	New York

Sponsors (1)

Lead Sponsor	Collaborator
The New York Eye & Ear Infirmary

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sclafani AP. Platelet-rich fibrin matrix for improvement of deep nasolabial folds. J Cosmet Dermatol. 2010 Mar;9(1):66-71. doi: 10.1111/j.1473-2165.2010.00486.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	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	No