Nasolabial FoldsPhase 1/2NCT00874094
Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds
A Phase 1/2 study testing Platelet rich fibrin matrix in people with Nasolabial Folds, run by The New York Eye & Ear Infirmary at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 25 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- Platelet rich fibrin matrix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jul 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults
- aged 25- 75 years
- with moderate to severe nasolabial folds
Who cannot join
- pregnant
- allergy to local anesthetics
- history of bleeding disorder
- active infection at the treatment site
- injectable filler in the nasolabial folds within past year
Trial locations and contacts
1 site in 1 country.
United States1 site
The New York Eye & Ear Infirmary- Otolaryngology Faculty practice satellite
Chappaqua, New York, 10514
About this study
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
- Being tested
- Platelet rich fibrin matrix
- Keywords
- nasolabial folds, platelet rich plasma, fibrin matrix, facial rhytids, dermal filler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich fibrin matrixBiological
0-2 cc of autologous platelet rich fibrin matrix injected intra and subdermally to effect nasolabial fold.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Platelet rich fibrin matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
Measured: 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
Measured: Pre-treatment to 6 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startApr 2008
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasolabial FoldsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The New York Eye & Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony P Sclafani, MD, Principal investigator, The New York Eye & Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874094
- Sponsor's protocol ID
- 08.01
- Status last verified
- Jul 2013
- First submitted
- 1 Apr 2009
- Last updated
- 12 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20367676
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT00874094
- Acronym / sponsor ID
- 08.01
- Conditions
- Nasolabial Folds
- Keywords
- nasolabial folds, platelet rich plasma, fibrin matrix, facial rhytids, dermal filler
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The New York Eye & Ear InfirmaryUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Posted 12 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| platelet rich fibrin matrix | Active comparator | Biological: Platelet rich fibrin matrixBoth nasolabial folds treated with 0-2 cc of autologous platelet rich fibrin matrix,sufficient to efface nasolabial fold |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy adults
- aged 25- 75 years
- with moderate to severe nasolabial folds
Key exclusion criteria (5 listed)
- pregnant
- allergy to local anesthetics
- history of bleeding disorder
- active infection at the treatment site
- injectable filler in the nasolabial folds within past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich fibrin matrix0-2 cc of autologous platelet rich fibrin matrix injected intra and subdermally to effect nasolabial fold. | Biological | platelet rich fibrin matrix |
Primary outcome
Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment.
Time frame: 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.
3 secondary outcomes
Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week
Time frame: pre-treatment to 1 week after treatment
Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks
Time frame: Pre-treatment to 2 weeks after treatment
Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks
Time frame: Pre-treatment to 6 weeks after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20367676Sclafani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony P Sclafani, MD principal investigator
The New York Eye & Ear Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Platelet rich fibrin matrix in people with Nasolabial Folds, run by The New York Eye & Ear Infirmary at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment. (time frame: Difference in Measurements taken Pre-treatment and 12 weeks after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00874094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2013.