AgingNCT04219293
Split Face Study of the Effects of Micro Needling With and Without Platelet Rich Plasma
A study testing Microneedling w/ and w/o PRP in people with Aging, run by Dallas Plastic Surgery Institute at 1 site in United States.
Trial summary
This pilot study will expand knowledge and application of 2 X concentration of Platelet Rich Plasma (PRP) in conjunction with microneedling using the SkinPen device. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Microneedling w/ and w/o PRP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2019to 1 Feb 2020
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females ages 30-60 years old.
- No previous minimally invasive or invasive skin resurfacing within the prior 12 months (i.e. fractionated laser, ablated laser, chemical peels, microneedling, etc…
- VisiaTM Scan showing aging including skin texture, wrinkles, brown spots, and pores.
- Patient willing to sign informed consent.
Who cannot join
- Keloid scars;
- History of eczema in treatment area; psoriasis and any other chronic skin conditions the Investigator determines disqualifies the patient for participation in treatment area;
- History of actinic (solar) keratosis in treatment area;
- History of hemophilia;
- History of diabetes;
- The presence of raised moles, warts on the targeted area.
- Absolute contraindications include; scleroderma, collagen vascular diseases or cardiac abnormalities; blood clotting problems; active bacterial or fungal infection; facial melanosis; malignant tumors, immunosuppression; use of blood thinners or prednisone; pregnant or nursing women; corticosteroids within two weeks of the procedure, chronic liver disease, porphyria or other skin diseases.
- Patient not willing to sign informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dallas Plastic Surgery Institute
Dallas, Texas, 75231
About this study
Official title: A Single-center, Randomized, Split Face Study of the Effects of Micro Needling With Platelet Rich Plasma Compared to Microneedling Without Platelet Rich Plasma
This pilot study will expand knowledge and application of 2 X concentration of Platelet Rich Plasma (PRP) in conjunction with microneedling using the SkinPen device.
Read the detailed description
There have been numerous studies demonstrating benefits of microneedling. However, to date there is no published research expanding on the benefits of using platelet rich plasma in conjunction with microneedling for facial aesthetics. This pilot study will expand knowledge and application of 2 X concentration of Platelet Rich Plasma (PRP) in conjunction with microneedling using the SkinPen device. The pilot aims to objectively measure skin quality using the Visia systemTM and provide objective data to compare Microneedling with the use of (PRP) versus microneedling without the use of PRP. The pilot also aims to subjectively measure skin improvement using the Face QTM and the Global Aesthetic Improvement ScaleTM.
- Conditions
- Aging
- Being tested
- Microneedling w/ and w/o PRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedling w/ and w/o PRPDevice
- Split face comparison. Vertical line drawn midline nose extending upwards to hairline and downwards to jawline separating face into two equal treatment areas. The patients determined side of face will be treated with SkinPen Microneedling and PRP the other (nondetermined from randomization) will be treated with SkinPen Microneedling and glide. The patient side of face that will not use PRP will be treated first. The following settings will be used as treatment protocol. Topical anesthetic Benzocaine 20%, Lidocaine 10%, and Tetracaine 10% will be applied covering entire treatment area. The anesthetic will remain on skin for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling with NO PRP | Other | Patient will receive Standard of Care micro needling on randomized side of the face. Receives: Device: Microneedling w/ and w/o PRP |
| Microneedling WITH PRP | Active comparator | Patient will receive Standard of care microneedling with PRP on randomized side of the face. Receives: Device: Microneedling w/ and w/o PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Skin improvement assessed by a Visia Scan.
The VISIA® facial scan uses 3-D imaging to accurately identify and quantify all aesthetic skin concerns, even before there are visible signs of damage or aging. Using a state-of-the-art, multi-point positioning system the visia scanner captures multiple angles of your skin.
Measured: 6 months
Overall Patient satisfaction of skin improvement assessed by the Global Aesthetic Improvement Scale.
The Global Aesthetic Improvement Scale (GAIS) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator.
Measured: 6 months
Overall Patient satisfaction of skin improvement assessed by the Face-Q Aesthetic Satisfaction with Outcome.
The FACE-Q© is a patient-reported outcome (PRO) measure that can be used to measure outcomes of. aesthetic facial procedures and products from the patient's perspective.
Measured: 6 months
Overall Patient satisfaction of skin improvement assessed by the Face-Q Aesthetic Satisfaction with Skin.
The FACE-Q© is a patient-reported outcome (PRO) measure that can be used to measure outcomes of. aesthetic facial procedures and products from the patient's perspective.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start26 Aug 2019
- Primary completion1 Jan 2020
- Study completion1 Feb 2020
Why it stopped: Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dallas Plastic Surgery Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219293
- Sponsor's protocol ID
- PRP01
- Status last verified
- Aug 2021
- First submitted
- 9 Dec 2019
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Split Face Study of the Effects of Micro Needling With Platelet Rich Plasma Compared to Microneedling Without Platelet Rich Plasma
- ClinicalTrials.gov ID
- NCT04219293
- Acronym / sponsor ID
- PRP01
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Dallas Plastic Surgery InstituteUniversity, hospital or other
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 7 Jan 2020 (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.
This pilot study will expand knowledge and application of 2 X concentration of Platelet Rich Plasma (PRP) in conjunction with microneedling using the SkinPen device.
Detailed description
There have been numerous studies demonstrating benefits of microneedling. However, to date there is no published research expanding on the benefits of using platelet rich plasma in conjunction with microneedling for facial aesthetics. This pilot study will expand knowledge and application of 2 X concentration of Platelet Rich Plasma (PRP) in conjunction with microneedling using the SkinPen device. The pilot aims to objectively measure skin quality using the Visia systemTM and provide objective data to compare Microneedling with the use of (PRP) versus microneedling without the use of PRP. The pilot also aims to subjectively measure skin improvement using the Face QTM and the Global Aesthetic Improvement ScaleTM.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microneedling with NO PRP | Other | Device: Microneedling w/ and w/o PRPPatient will receive Standard of Care micro needling on randomized side of the face. |
| Microneedling WITH PRP | Active comparator | Device: Microneedling w/ and w/o PRPPatient will receive Standard of care microneedling with PRP on randomized side of the face. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males and females ages 30-60 years old.
- No previous minimally invasive or invasive skin resurfacing within the prior 12 months (i.e. fractionated laser, ablated laser, chemical peels, microneedling, etc…
- VisiaTM Scan showing aging including skin texture, wrinkles, brown spots, and pores.
- Patient willing to sign informed consent.
Key exclusion criteria (8 listed)
- Keloid scars;
- History of eczema in treatment area; psoriasis and any other chronic skin conditions the Investigator determines disqualifies the patient for participation in treatment area;
- History of actinic (solar) keratosis in treatment area;
- History of hemophilia;
- History of diabetes;
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 |
|---|---|---|
| Microneedling w/ and w/o PRPi. Split face comparison. Vertical line drawn midline nose extending upwards to hairline and downwards to jawline separating face into two equal treatment areas. The patients determined side of face will be treated with SkinPen Microneedling and PRP the other (nondetermined from randomization) will be treated with SkinPen Microneedling and glide. The patient side of face that will not use PRP will be treated first. The following settings will be used as treatment protocol. Topical anesthetic Benzocaine 20%, Lidocaine 10%, and Tetracaine 10% will be applied covering entire treatment area. The anesthetic will remain on skin for 30 minutes. | Device | Microneedling WITH PRP, Microneedling with NO PRP |
Primary outcome
Overall Skin improvement assessed by a Visia Scan.
Time frame: 6 months
The VISIA® facial scan uses 3-D imaging to accurately identify and quantify all aesthetic skin concerns, even before there are visible signs of damage or aging. Using a state-of-the-art, multi-point positioning system the visia scanner captures multiple angles of your skin.
Overall Patient satisfaction of skin improvement assessed by the Global Aesthetic Improvement Scale.
Time frame: 6 months
The Global Aesthetic Improvement Scale (GAIS) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator.
Overall Patient satisfaction of skin improvement assessed by the Face-Q Aesthetic Satisfaction with Outcome.
Time frame: 6 months
The FACE-Q© is a patient-reported outcome (PRO) measure that can be used to measure outcomes of. aesthetic facial procedures and products from the patient's perspective.
Overall Patient satisfaction of skin improvement assessed by the Face-Q Aesthetic Satisfaction with Skin.
Time frame: 6 months
The FACE-Q© is a patient-reported outcome (PRO) measure that can be used to measure outcomes of. aesthetic facial procedures and products from the patient's perspective.
Results and safety
The study was stopped early (reason given: Covid-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- 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 Microneedling w/ and w/o PRP in people with Aging, run by Dallas Plastic Surgery Institute 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 11 Aug 2021. 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.
Are results available for this study?
The study was stopped early (reason given: Covid-19). Results are not available in the source record.
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?
Overall Skin improvement assessed by a Visia Scan. (time frame: 6 months). The study lists 4 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 11 Aug 2021.