Phase 2
N=15
Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds
Nasolabial Folds
Bottom Line
View on ClinicalTrials.gov: NCT00874094 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment. — 1.13 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Platelet rich fibrin matrix (Biological)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- Female
- Sponsor
- The New York Eye & Ear Infirmary
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment. |
1.13 | — |
| SECONDARY Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week |
.65 | — |
| SECONDARY Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks |
.97 | — |
| SECONDARY Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks |
1.08 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00874094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.