Skin RejuvenationNCT04128046
The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation
A study testing PRFM injection and Saline injection in people with Skin Rejuvenation and Skin Quality, run by New York Medical College at 1 site in United States.
Trial summary
Platelet-rich fibrin matrix (PRFM) is made from platelets that are extracted from a patient's blood, and many plastic surgeons and dermatologists have used it to fill in wrinkles and lines on the face. Both patients and doctors have observed that it gives extra volume in these areas and improves overall appearance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Rejuvenation, Skin Quality, Wrinkle
- What is being tested?
- PRFM injection and Saline injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 years of age and older who had a dermatological concern, specifically, conspicuous spots, pores, rhytids, uneven texture, or red or brown discoloration, and a VISIA complexion analysis score greater than 10
- Agreed to continue any contraceptive hormonal therapy for duration of the study
- Agreed to not initiate the use of hormonal therapy during the study
- Agreed to not undergo any facial procedures or treatments, including injections and fillers, lasers, peels, and topical therapies, during the duration of the study
- Agreed to adhere to a standardized skin care regimen throughout the duration of the study consisting of the use of a single cleanser and moisturizer twice a day
- Agreed to refrain from excessive sun exposure/tanning
Who cannot join
- History of skin/connective tissue disorders
- History of immunosuppressive therapy or radiotherapy
- Participation in facial procedures, such as injections, lasers, peels, and dermabrasion, in the last six months
- Use of topical/prescription acne medications in the last three months
- Current smokers or prior smokers who quit fewer than 10 years ago
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation: A Split Face Comparison
Platelet-rich fibrin matrix (PRFM) is made from platelets that are extracted from a patient's blood, and many plastic surgeons and dermatologists have used it to fill in wrinkles and lines on the face. Both patients and doctors have observed that it gives extra volume in these areas and improves overall appearance. However, there is no research that shows how PRFM affects skin quality, such as pores, spots, red areas, and texture. The aim of this study is to determine whether PRFM has a role in rejuvenating facial skin.
- Conditions
- Skin Rejuvenation, Skin Quality, Wrinkle, Nasolabial Fold
- Being tested
- PRFM injection, Saline injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRFM injectionProcedure or surgery
Using a 27-gauge microcannula, a total of 4 mL of PRFM was injected intradermally into the mid-cheek and NLF (2 mL for each site) on one side of the face.
Saline injectionProcedure or surgery
Using a 27-gauge microcannula, a total of 4 mL of saline was injected intradermally into the mid-cheek and NLF (2 mL for each site) on the contralateral side of the face.
| Study group | Role | What they receive |
|---|---|---|
| PRFM | Experimental | Hemi-face injected with PRFM. PRFM was produced from 9 mL of blood (Healeon Medical, Inc). Receives: Procedure: PRFM injection |
| Saline | Placebo comparator | Hemi-face injected with saline. Receives: Procedure: Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VISIA skin score
Difference between pre- and post-treatment VISIA analysis scores for skin parameters of spots, wrinkles, texture, and pores
Measured: Skin analysis performed at initial visit, at 6 weeks, and at 12 weeks following initial treatment
Secondary outcomes (3)
Change in Wrinkle Severity Rating Scale
Difference between pre- and post-treatment quantitative grading of nasolabial folds for each group. Graded from 1 through 5, with 5 representing the worst score
Measured: Rating occurred at initial visit, at 6 weeks, and at 12 weeks following initial treatment
Skin Rejuvenation Outcomes Evaluation (SROE)
Patient-reported outcome measure validated for skin resurfacing techniques. Each item is rated on a 0-4 scale. The final score is computed by dividing the total score for the instrument by 24 and multiplying by 100, giving a range of 0-100. The difference in the change in SROE score for each cohort was calculated.
Measured: Evaluation distributed at initial visit, at 6 weeks, and at 12 weeks following treatment.
VISIA Outcomes Questionnaire
Evaluation targeted specifically at identifying changes in the skin parameters analyzed by VISIA. Each item is rated on a 0-4 scale. The final score is computed by dividing the total score for the instrument by 24 and multiplying by 100, giving a range of 0-100. The difference in the change in VISIA outcomes score for each cohort was calculated.
Measured: Evaluation distributed at initial visit, at 6 weeks, and at 12 weeks following treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start3 Sep 2018
- Primary completion28 May 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin RejuvenationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manoj Abraham, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128046
- Sponsor's protocol ID
- 12698
- Status last verified
- Oct 2019
- First submitted
- 13 Oct 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation: A Split Face Comparison
- ClinicalTrials.gov ID
- NCT04128046
- Acronym / sponsor ID
- 12698
- Conditions
- Skin Rejuvenation, Skin Quality, Wrinkle, Nasolabial Fold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Platelet-rich fibrin matrix (PRFM) is made from platelets that are extracted from a patient's blood, and many plastic surgeons and dermatologists have used it to fill in wrinkles and lines on the face. Both patients and doctors have observed that it gives extra volume in these areas and improves overall appearance. However, there is no research that shows how PRFM affects skin quality, such as pores, spots, red areas, and texture. The aim of this study is to determine whether PRFM has a role in rejuvenating facial skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRFM | Experimental | Procedure: PRFM injectionHemi-face injected with PRFM. PRFM was produced from 9 mL of blood (Healeon Medical, Inc). |
| Saline | Placebo comparator | Procedure: Saline injectionHemi-face injected with saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults 18 years of age and older who had a dermatological concern, specifically, conspicuous spots, pores, rhytids, uneven texture, or red or brown discoloration, and a VISIA complexion analysis score greater than 10
- Agreed to continue any contraceptive hormonal therapy for duration of the study
- Agreed to not initiate the use of hormonal therapy during the study
- Agreed to not undergo any facial procedures or treatments, including injections and fillers, lasers, peels, and topical therapies, during the duration of the study
- Agreed to adhere to a standardized skin care regimen throughout the duration of the study consisting of the use of a single cleanser and moisturizer twice a day
Key exclusion criteria (5 listed)
- History of skin/connective tissue disorders
- History of immunosuppressive therapy or radiotherapy
- Participation in facial procedures, such as injections, lasers, peels, and dermabrasion, in the last six months
- Use of topical/prescription acne medications in the last three months
- Current smokers or prior smokers who quit fewer than 10 years ago
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 |
|---|---|---|
| PRFM injectionUsing a 27-gauge microcannula, a total of 4 mL of PRFM was injected intradermally into the mid-cheek and NLF (2 mL for each site) on one side of the face. | Procedure or surgery | PRFM |
| Saline injectionUsing a 27-gauge microcannula, a total of 4 mL of saline was injected intradermally into the mid-cheek and NLF (2 mL for each site) on the contralateral side of the face. | Procedure or surgery | Saline |
Primary outcome
Change in VISIA skin score
Time frame: Skin analysis performed at initial visit, at 6 weeks, and at 12 weeks following initial treatment
Difference between pre- and post-treatment VISIA analysis scores for skin parameters of spots, wrinkles, texture, and pores
3 secondary outcomes
Change in Wrinkle Severity Rating Scale
Time frame: Rating occurred at initial visit, at 6 weeks, and at 12 weeks following initial treatment
Skin Rejuvenation Outcomes Evaluation (SROE)
Time frame: Evaluation distributed at initial visit, at 6 weeks, and at 12 weeks following treatment.
VISIA Outcomes Questionnaire
Time frame: Evaluation distributed at initial visit, at 6 weeks, and at 12 weeks following treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRFM injection and Saline injection in people with Skin Rejuvenation and Skin Quality, run by New York Medical College 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 6 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 22 Oct 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in VISIA skin score (time frame: Skin analysis performed at initial visit, at 6 weeks, and at 12 weeks following initial treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2019.