Skin Aging of Face and HandsEarly Phase 1PRPNCT03647917

A Pilot Study on the Use of Platelet Rich Plasma (PRP) for Facial and Hand Skin Rejuvenation

A Early Phase 1 study testing Platelet Rich Plasma in people with Skin Aging of Face and Hands, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The overall goal of this study is to develop regenerative cell therapy for use in female patients with aging skin. The primary objective of this proposal is to conduct a pilot study on the efficacy and safety of using PRP to treat this condition in females. Read more about this study

Who is it for?: Ages 45 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Skin Aging of Face and Hands
What is being tested?: Platelet Rich Plasma
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 18 Jun 2019to 7 Jun 2021
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 45 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Only female patients are eligible
Patients must be 45 years of age or older
Patients must have signs of skin aging on face (wrinkles, rough texture, skin atrophy and skin laxity) and hands (loss of fat tissue and visibility of veins and tendons).
Patients must have been on stable birth control for the past 6 months if able to conceive
Patients are able and willing to provide written informed consent after the study is fully explained

Who cannot join

Patients with clinically abnormal platelet count, serum chemistry, or screening laboratory results as reviewed by the Principal Investigator
Patients who have had any cosmetic procedures meant to address skin aging of face and hands 3 months prior to enrollment
Patients who have had resurfacing laser on face or hands within one year prior to enrollment
Patients taking anti-rheumatic disease medication (including methotrexate or other anti-metabolites) within the 3 months prior to study entry
Patients who are pregnant or currently breast-feeding
Patients with systemic, rheumatic, or inflammatory disease or who are immunosuppressed

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Patients with ongoing infectious disease, including HIV and hepatitis
Patients with history of significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes
Patients participating in a study of an experimental drug or medical device within 30 days of study entry
Patients with history of platelet disorders, bone marrow aplasia, sepsis, or cancer
Patients taking anti-aggregating therapy
Patients on anticoagulant therapy
Patients with history of keloid formation
Patients with uncontrolled diabetes
Patients with active skin disease or skin infection on the intended treatment areas, at baseline

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Florida
Jacksonville, Florida, 32224

Other trials in United States

About this study

Official title: A Pilot, Randomized, Single-Blind, Controlled Study Evaluating the Use of Platelet Rich Plasma (PRP) and Microneedling for Facial and Hand Skin Rejuvenation

Read the detailed description

Recently, there has been interest in treatments which are orientated to more biologically regenerative therapies, with several studies demonstrating successful use for PRP in skin rejuvenation. Although PRP is widely used in clinical dermatology, experimental studies confirming the effects of PRP on aged fibroblasts are very limited.

PRP contains concentrated platelet cells derived from autologous whole blood that are believed to induce the synthesis of collagen and other matrix components by stimulating the activation of fibroblasts, thus rejuvenating the skin when injected into an area of collagen degeneration. In this proposal we will examine whether PRP therapy provides similar or better rejuvenating capacity in women compared to saline solution. The study will be a randomized, controlled trial comparing microneedling with PRP to microneedling with saline solution, in females aged 45 and over with skin aging of face. This study will also compare PRP to saline (given through injections via filler injection technique) in females with aging skin of the hands. Microneedling will not be performed on the hands.

Conditions: Skin Aging of Face and Hands
Being tested: Platelet Rich Plasma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Platelet Rich PlasmaBiological
Autologous Platelet Rich Plasma (PRP) will be isolated from the blood collected from each subject at each treatment time point.
Face: Using a 30 gage needle, about four points of PRP or saline will be injected into the malar area; about six points will be injected into the mandibular area; and seven points will be injected into the forehead (0.2 mL per point) with a total volume of approximately 3.5 mL. PRP and saline application will be followed by microneedling.
Hands: Using a 30 gage needle about 1 cc of PRP or saline will be injected into the dorsal area of the hands (0.2mL per point) at five points. No microneedling will be performed on the hands.
Platelet Rich PlasmaBiological
Autologous Platelet Rich Plasma (PRP) will be isolated from the blood collected from each subject at each treatment time point.
Face: Using a 30 gage needle, about four points of PRP or saline will be injected into the malar area; about six points will be injected into the mandibular area; and seven points will be injected into the forehead (0.2 mL per point) with a total volume of approximately 3.5 mL. PRP and saline application will be followed by microneedling.
Hands: Using a 30 gage needle about 1 cc of PRP or saline will be injected into the dorsal area of the hands (0.2mL per point) at five points. No microneedling will be performed on the hands.

Study groups in NCT03647917
Study group	Role	What they receive
Platelet Rich Plasma, Left face and hands	Experimental	Subjects will receive PRP on left half of face and saline solution on right half of face through injections via filler injection technique followed by microneedling, and will also receive PRP on dorsal part of left hand and saline solution on dorsal part of right hand through injections via filler injection technique. Microneedling will not be performed on the hands. Injections will take place every 4 weeks for a total of 3 treatments. Receives: Biological: Platelet Rich Plasma
Platelet Rich Plasma, Right face and hands	Experimental	Subjects will receive PRP on right half of face and saline solution on left half of face through injections via filler injection technique followed by microneedling, and will also receive PRP on dorsal part of right hand and saline solution on dorsal part of left hand, through injections via filler injection technique. Microneedling will not be performed on the hands. Injections will take place every 4 weeks for a total of 3 treatments. Receives: Biological: Platelet Rich Plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

Wrinkle Severity Rating Scale (WSRS)
The Wrinkle Severity Rating Scale assesses the presence and severity of wrinkles at rest in a rating scale from 0 to 4, where 0 means no visible wrinkles, 1 means minimal wrinkles, 2 means shallow wrinkles, 3 means moderately deep wrinkles and 4 means very deep wrinkles.
Measured: 24 weeks

Secondary outcomes (1)

Hand Grading Scale
The Hand Grading Scale assesses signs of hand aging based on loss of fat tissue and visibility of veins and tendons. It is rating scale form 0 to 4 where 0 means no loss of fat tissue, 1 means mild loss of fat tissue and slight visibility of veins, 2 means moderate loss of fat tissue and mild visibility of veins and tendons, 3 means severe loss of fat tissue and moderate visibility of veins and tendons and 4 means very severe loss of fat tissue and marked visibility of veins and tendons.
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jun 20197 Jun 2021

First posted27 Aug 2018
Study start18 Jun 2019
Primary completion7 Jun 2021
Study completion7 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Skin Aging of Face and HandsStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
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: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03647917
Sponsor's protocol ID: 17-005431
Acronym: PRP
Status last verified: Nov 2021
First submitted: 29 Jun 2018
Last updated: 24 Nov 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot, Randomized, Single-Blind, Controlled Study Evaluating the Use of Platelet Rich Plasma (PRP) and Microneedling for Facial and Hand Skin Rejuvenation
ClinicalTrials.gov ID: NCT03647917
Acronym / sponsor ID: PRP / 17-005431
Conditions: Skin Aging of Face and Hands
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 18 Jun 2019 (actual)
Primary completion: 7 Jun 2021 (actual)
Study completion: 7 Jun 2021 (actual)
First posted: 27 Aug 2018 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Platelet Rich Plasma, Left face and hands	Experimental	Biological: Platelet Rich PlasmaSubjects will receive PRP on left half of face and saline solution on right half of face through injections via filler injection technique followed by microneedling, and will also receive PRP on dorsal part of left hand and saline solution on dorsal part of right hand through injections via filler injection technique. Microneedling will not be performed on the hands. Injections will take place every 4 weeks for a total of 3 treatments.
Platelet Rich Plasma, Right face and hands	Experimental	Biological: Platelet Rich PlasmaSubjects will receive PRP on right half of face and saline solution on left half of face through injections via filler injection technique followed by microneedling, and will also receive PRP on dorsal part of right hand and saline solution on dorsal part of left hand, through injections via filler injection technique. Microneedling will not be performed on the hands. Injections will take place every 4 weeks for a total of 3 treatments.

Who may qualify

Ages: 45 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Only female patients are eligible
Patients must be 45 years of age or older
Patients must have signs of skin aging on face (wrinkles, rough texture, skin atrophy and skin laxity) and hands (loss of fat tissue and visibility of veins and tendons).
Patients must have been on stable birth control for the past 6 months if able to conceive
Patients are able and willing to provide written informed consent after the study is fully explained

Key exclusion criteria (15 listed)

Patients with clinically abnormal platelet count, serum chemistry, or screening laboratory results as reviewed by the Principal Investigator
Patients who have had any cosmetic procedures meant to address skin aging of face and hands 3 months prior to enrollment
Patients who have had resurfacing laser on face or hands within one year prior to enrollment
Patients taking anti-rheumatic disease medication (including methotrexate or other anti-metabolites) within the 3 months prior to study entry
Patients who are pregnant or currently breast-feeding

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 PlasmaAutologous Platelet Rich Plasma (PRP) will be isolated from the blood collected from each subject at each treatment time point. Face: Using a 30 gage needle, about four points of PRP or saline will be injected into the malar area; about six points will be injected into the mandibular area; and seven points will be injected into the forehead (0.2 mL per point) with a total volume of approximately 3.5 mL. PRP and saline application will be followed by microneedling. Hands: Using a 30 gage needle about 1 cc of PRP or saline will be injected into the dorsal area of the hands (0.2mL per point) at five points. No microneedling will be performed on the hands.	Biological	Platelet Rich Plasma, Left face and hands
Platelet Rich PlasmaAutologous Platelet Rich Plasma (PRP) will be isolated from the blood collected from each subject at each treatment time point. Face: Using a 30 gage needle, about four points of PRP or saline will be injected into the malar area; about six points will be injected into the mandibular area; and seven points will be injected into the forehead (0.2 mL per point) with a total volume of approximately 3.5 mL. PRP and saline application will be followed by microneedling. Hands: Using a 30 gage needle about 1 cc of PRP or saline will be injected into the dorsal area of the hands (0.2mL per point) at five points. No microneedling will be performed on the hands.	Biological	Platelet Rich Plasma, Right face and hands

Primary outcome

Wrinkle Severity Rating Scale (WSRS)
Time frame: 24 weeks
The Wrinkle Severity Rating Scale assesses the presence and severity of wrinkles at rest in a rating scale from 0 to 4, where 0 means no visible wrinkles, 1 means minimal wrinkles, 2 means shallow wrinkles, 3 means moderately deep wrinkles and 4 means very deep wrinkles.

1 secondary outcome

Hand Grading Scale
Time frame: 24 weeks

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 24 Nov 2021.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

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.

Alison J Bruce, MD principal investigator

Mayo Clinic

Thais P Pincelli, MD principal investigator

Mayo Clinic

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 Platelet Rich Plasma in people with Skin Aging of Face and Hands, run by Mayo Clinic 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 5 inclusion and 15 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 24 Nov 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.

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?

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?

Wrinkle Severity Rating Scale (WSRS) (time frame: 24 weeks). 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 NCT03647917.

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 24 Nov 2021.