Tear Trough Hollowing, Under Eye BagsEarly Phase 1NCT03313934
Platelet Rich Fibrin for Tear Trough Rejuvenation
A Early Phase 1 study testing Hyaluronic Acid Filler and Platelet Rich Fibrin (PRF) and Hyaluronic Acid Filler and Saline in people with Tear Trough Hollowing, Under Eye Bags, run by Rejuva Medical Aesthetics at 1 site in United States.
Trial summary
The purpose of this study is to investigate the efficacy and longevity of Platelet Rich Fibrin (PRF) in combination with hyaluronic acid filler for cosmetic volume restoration of the tear troughs. This study will also evaluate visible improvement in skin texture that may be attributable to the added PRF. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tear Trough Hollowing, Under Eye Bags
- What is being tested?
- Hyaluronic Acid Filler and Platelet Rich Fibrin (PRF) and Hyaluronic Acid Filler and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2017to Nov 2018
- Phase
- Early Phase 1
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males/females aged 20-80 who are experiencing moderate volume loss of the tear troughs and/or under eye bags. Eligible subjects will be in generally good health and able to provide a blood sample for treatment.
Who cannot join
- Those who fall outside of the age range 20-80 years of age, with chronic health problems including but not limited to thyroid disorders, cancer, blood disease, etc. Those who do not demonstrate volume loss of the tear troughs to the degree that warrants intervention. Conversely, those who are better suited for surgical intervention as opposed to non-surgical injections will not be eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rejuva Medical Aesthetics
Los Angeles, California, 90025
About this study
Official title: Platelet Rich Fibrin (PRF) With Hyaluronic Acid Fillers for Tear Trough Rejuvenation
The purpose of this study is to investigate the efficacy and longevity of Platelet Rich Fibrin (PRF) in combination with hyaluronic acid filler for cosmetic volume restoration of the tear troughs. This study will also evaluate visible improvement in skin texture that may be attributable to the added PRF.
Read the detailed description
Background: Platelet therapy is quickly becoming an integral aspect of cosmetic treatments. Most notably, Platelet Rich Plasma (PRP) has been used topically or as an injection to stimulate collagen production and enhance the efficacy of cosmetic procedures such as fat transfer, hair loss, laser treatments, and microneedling. Harvested PRP has platelets, fibrin, and white blood cells, which contribute to wound healing, neocollagenesis, and elastogenesis. Platelet Rich Fibrin (PRF) is the next generation of PRP and contains very high concentrations white blood cells, fibrin and a small amount of mesenchymal stem cells found circulating in our bloodstreams. Due to a lack of anticoagulant in the tube, PRF becomes a gel after 15-20 minutes of being isolated. This is useful in reconstructive and aesthetic medicine, which allows it to be used for cosmetic volume restoration in addition to topical indications.
Hyaluronic acid fillers have become increasingly popular in aesthetic medicine over the past two decades. Hyaluronic acid fillers are synthesized in a variety of different ways and last anywhere from 6 to 24 months, depending on the volume and location of the face or body they are injected. Fillers under the eyes in the "tear trough" area are popular treatments to allow patients to appear more refreshed and rested. Although this is an "off label" application of injectable fillers, it is extremely popular and is performed safely in many aesthetic clinics worldwide. Given that PRF can be used to restore volume, it will be determined if PRF in combination with hyaluronic acid filler will enhance resultant volume and skin quality in the treated areas.
Objective: The purpose of this study is to investigate the efficacy and longevity of Platelet Rich Fibrin (PRF) in combination with hyaluronic acid filler for cosmetic volume restoration of the tear troughs. This study will also evaluate visible improvement in skin texture that may be attributable to the added PRF.
Hypothesis: The addition of Platelet Rich Fibrin (PRF) to hyaluronic acid fillers contribute to volume restoration of the tear trough and also improve the texture and quality of the skin in the treated area. The patient will perceive a more natural and improved result on the PRF-treated side.
- Conditions
- Tear Trough Hollowing, Under Eye Bags
- Being tested
- Hyaluronic Acid Filler and Platelet Rich Fibrin (PRF), Hyaluronic Acid Filler and Saline
- Keywords
- Hyaluronic Acid Filler, Platelet Rich Fibrin (PRF), Tear Trough Filler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid Filler and Platelet Rich Fibrin (PRF)Combination product
Also called Restylane-L
The use of Restylane-L to volumize the tear trough has been well documented. Combining Restylane-L with Platelet Rich Fibrin (PRF) will be studied to evaluate if PRF enhances the volumization and skin quality of the treated areas.
Hyaluronic Acid Filler and SalineCombination product
Also called Restylane-L
This intervention will use saline as a control to compare with PRF when mixed with hyaluronic acid fillers. Saline will dilute the HA filler in the same way PRF will, however saline as no growth factors or properties that will enhance treatment.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic Acid Filler with Saline | Placebo comparator | For each subject, one tear trough will be injected with hyaluronic acid filler mixed with saline. This arm will act as a control to evaluate the efficacy of PRF with hyaluronic acid. Receives: Combination Product: Hyaluronic Acid Filler and Saline |
| Hyaluronic Acid Filler with Platelet Rich Fibrin (PRF) | Experimental | For each subject, one tear trough will be injected with hyaluronic acid filler mixed with Platelet Rich Fibrin (PRF). This study seeks to determine the efficacy of PRF in volumization of the tear trough and improvement of skin quality. This is the experimental condition. Receives: Combination Product: Hyaluronic Acid Filler and Platelet Rich Fibrin (PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Tear Trough Rejuvenation
Restoration of volume loss and improved skin quality of the tear troughs
Measured: 1 month
Improvement of Facial Rhytids
Reduction in wrinkles and appearance of "crepey" skin.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study startNov 2017 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tear Trough Hollowing, Under Eye BagsStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 10 subjects will receive treatment with hyaluronic acid fillers for tear trough rejuvenation. Each subject with have one tear trough treated with HA filler mixed with Platelet Rich Fibrin, and the other tear trough injected with HA filler mixed with saline. The subject with be blind as to which tear trough contains the PRF. This will be randomly assigned for each subject and documented by the CRC.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rejuva Medical Aesthetics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Reivitis, Rejuva Medical Aesthetics
- Investigators
- Kian Karimi, MD,FACS, Principal investigator, Rejuva Medical Aesthetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313934
- Sponsor's protocol ID
- 20171835
- Status last verified
- Oct 2017
- First submitted
- 13 Oct 2017
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be collected, organized, and summarized in a manuscript to be submitted for publication. The publication will be available for other researchers to review.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Fibrin (PRF) With Hyaluronic Acid Fillers for Tear Trough Rejuvenation
- ClinicalTrials.gov ID
- NCT03313934
- Acronym / sponsor ID
- 20171835
- Conditions
- Tear Trough Hollowing, Under Eye Bags
- Keywords
- Hyaluronic Acid Filler, Platelet Rich Fibrin (PRF), Tear Trough Filler
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Rejuva Medical AestheticsUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 18 Oct 2017 (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.
The purpose of this study is to investigate the efficacy and longevity of Platelet Rich Fibrin (PRF) in combination with hyaluronic acid filler for cosmetic volume restoration of the tear troughs. This study will also evaluate visible improvement in skin texture that may be attributable to the added PRF.
Detailed description
Background: Platelet therapy is quickly becoming an integral aspect of cosmetic treatments. Most notably, Platelet Rich Plasma (PRP) has been used topically or as an injection to stimulate collagen production and enhance the efficacy of cosmetic procedures such as fat transfer, hair loss, laser treatments, and microneedling. Harvested PRP has platelets, fibrin, and white blood cells, which contribute to wound healing, neocollagenesis, and elastogenesis. Platelet Rich Fibrin (PRF) is the next generation of PRP and contains very high concentrations white blood cells, fibrin and a small amount of mesenchymal stem cells found circulating in our bloodstreams. Due to a lack of anticoagulant in the tube, PRF becomes a gel after 15-20 minutes of being isolated. This is useful in reconstructive and aesthetic medicine, which allows it to be used for cosmetic volume restoration in addition to topical indications.
Hyaluronic acid fillers have become increasingly popular in aesthetic medicine over the past two decades. Hyaluronic acid fillers are synthesized in a variety of different ways and last anywhere from 6 to 24 months, depending on the volume and location of the face or body they are injected. Fillers under the eyes in the "tear trough" area are popular treatments to allow patients to appear more refreshed and rested. Although this is an "off label" application of injectable fillers, it is extremely popular and is performed safely in many aesthetic clinics worldwide. Given that PRF can be used to restore volume, it will be determined if PRF in combination with hyaluronic acid filler will enhance resultant volume and skin quality in the treated areas.
Objective: The purpose of this study is to investigate the efficacy and longevity of Platelet Rich Fibrin (PRF) in combination with hyaluronic acid filler for cosmetic volume restoration of the tear troughs. This study will also evaluate visible improvement in skin texture that may be attributable to the added PRF.
Hypothesis: The addition of Platelet Rich Fibrin (PRF) to hyaluronic acid fillers contribute to volume restoration of the tear trough and also improve the texture and quality of the skin in the treated area. The patient will perceive a more natural and improved result on the PRF-treated side.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 10 subjects will receive treatment with hyaluronic acid fillers for tear trough rejuvenation. Each subject with have one tear trough treated with HA filler mixed with Platelet Rich Fibrin, and the other tear trough injected with HA filler mixed with saline. The subject with be blind as to which tear trough contains the PRF. This will be randomly assigned for each subject and documented by the CRC.
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic Acid Filler with Saline | Placebo comparator | Combination Product: Hyaluronic Acid Filler and SalineFor each subject, one tear trough will be injected with hyaluronic acid filler mixed with saline. This arm will act as a control to evaluate the efficacy of PRF with hyaluronic acid. |
| Hyaluronic Acid Filler with Platelet Rich Fibrin (PRF) | Experimental | Combination Product: Hyaluronic Acid Filler and Platelet Rich Fibrin (PRF)For each subject, one tear trough will be injected with hyaluronic acid filler mixed with Platelet Rich Fibrin (PRF). This study seeks to determine the efficacy of PRF in volumization of the tear trough and improvement of skin quality. This is the experimental condition. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males/females aged 20-80 who are experiencing moderate volume loss of the tear troughs and/or under eye bags. Eligible subjects will be in generally good health and able to provide a blood sample for treatment.
Key exclusion criteria (1 listed)
- Those who fall outside of the age range 20-80 years of age, with chronic health problems including but not limited to thyroid disorders, cancer, blood disease, etc. Those who do not demonstrate volume loss of the tear troughs to the degree that warrants intervention. Conversely, those who are better suited for surgical intervention as opposed to non-surgical injections will not be eligible.
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 |
|---|---|---|
| Hyaluronic Acid Filler and Platelet Rich Fibrin (PRF)Also: Restylane-LThe use of Restylane-L to volumize the tear trough has been well documented. Combining Restylane-L with Platelet Rich Fibrin (PRF) will be studied to evaluate if PRF enhances the volumization and skin quality of the treated areas. | Combination product | Hyaluronic Acid Filler with Platelet Rich Fibrin (PRF) |
| Hyaluronic Acid Filler and SalineAlso: Restylane-LThis intervention will use saline as a control to compare with PRF when mixed with hyaluronic acid fillers. Saline will dilute the HA filler in the same way PRF will, however saline as no growth factors or properties that will enhance treatment. | Combination product | Hyaluronic Acid Filler with Saline |
Primary outcome
Overall Tear Trough Rejuvenation
Time frame: 1 month
Restoration of volume loss and improved skin quality of the tear troughs
Improvement of Facial Rhytids
Time frame: 12 months
Reduction in wrinkles and appearance of "crepey" skin.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Individual participant dataSharing planned: Undecided. The data will be collected, organized, and summarized in a manuscript to be submitted for publication. The publication will be available for other researchers to review.
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.
Kian Karimi, MD,FACS principal investigator
Rejuva Medical Aesthetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hyaluronic Acid Filler and Platelet Rich Fibrin (PRF) and Hyaluronic Acid Filler and Saline in people with Tear Trough Hollowing, Under Eye Bags, run by Rejuva Medical Aesthetics 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Oct 2017. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alex N Reivitis, BA (4246442400, alex@rejuvamedical.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Tear Trough Rejuvenation (time frame: 1 month). The study lists 2 primary outcomes in all. 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 18 Oct 2017.