Nasolabial Folds
Conditions
Keywords
nasolabial folds, platelet rich plasma, fibrin matrix, facial rhytids, dermal filler
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.
Interventions
BIOLOGICALPlatelet rich fibrin matrix
0-2 cc of autologous platelet rich fibrin matrix injected intra and subdermally to effect nasolabial fold.
Sponsors
The New York Eye & Ear Infirmary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment. | Difference in Measurements taken Pre-treatment and 12 weeks after 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week | pre-treatment to 1 week after treatment | 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 |
| Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks | Pre-treatment to 2 weeks after treatment | 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 |
| Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks | Pre-treatment to 6 weeks after treatment | 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 |
Countries
United States
Participant flow
Recruitment details
Patients with moderate to severe nasolabial folds were included.
Pre-assignment details
Any patient who refused to attend all scheduled follow up visits were to be excluded.
Participants by arm
| Arm | Count |
|---|---|
| Treatment With Platelet Rich Fibrin Matrix Both nasolabial folds treated with platelet rich fibrin matrix | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Treatment With Platelet Rich Fibrin Matrix |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age Continuous | 54.27 years STANDARD_DEVIATION 12.11 |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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.
Time frame: Difference in Measurements taken Pre-treatment and 12 weeks after treatment.
Population: Number of participants were calculated based on need to achieve 1 unit improvement of Wrinkle Assessment score over baseline (pre-treatment) to be clinically relevant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment With Platelet Rich Fibrin Matrix | Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment. | 1.13 units on a scale | Standard Deviation 0.76 |
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
Time frame: Pre-treatment to 2 weeks after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment With Platelet Rich Fibrin Matrix | Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks | .97 units on a scale | Standard Deviation 0.75 |
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
Time frame: Pre-treatment to 6 weeks after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment With Platelet Rich Fibrin Matrix | Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks | 1.08 units on a scale | Standard Deviation 0.59 |
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
Time frame: pre-treatment to 1 week after treatment
Population: The number of participants required to demonstrate a 1 point difference between pre and post treatment values
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment With Platelet Rich Fibrin Matrix | Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week | .65 units on a scale | Standard Deviation 0.68 |