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

NCT00874094 | Completed Phase 1 Results

• 1 other identifier: 08.01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasolabial Folds

Keywords

nasolabial folds; platelet rich plasma; fibrin matrix; facial rhytids; dermal filler

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week

  pre-treatment to 1 week after treatment

• Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks

  Pre-treatment to 2 weeks after treatment

• Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks

  Pre-treatment to 6 weeks after treatment

Study Arms (1)

platelet rich fibrin matrix

ACTIVE COMPARATOR

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

Biological: Platelet rich fibrin matrix

Interventions

Platelet rich fibrin matrix BIOLOGICAL

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

platelet rich fibrin matrix

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy adults
• aged 25- 75 years
• with moderate to severe nasolabial folds

You may not qualify if:

• pregnant
• allergy to local anesthetics
• history of bleeding disorder
• active infection at the treatment site
• injectable filler in the nasolabial folds within past year

Sponsors & Collaborators

• The New York Eye & Ear Infirmary: lead

Study Sites (1)

The New York Eye & Ear Infirmary- Otolaryngology Faculty practice satellite

Chappaqua, New York, 10514, United States

Location

Related 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.

  PMID: 20367676 RESULT

Results Point of Contact

• Title: Anthony P Sclafani, MD
• Organization: NY Eye & Ear Infirmary

asclafani@nyee.edu

212-979-4200

Study Officials

• Anthony P Sclafani, MD

  The New York Eye & Ear Infirmary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: April 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 12, 2013
• Results First Posted: July 12, 2013

Record last verified: 2013-07

Locations

US (1)