A Pilot Study on the Use of Platelet Rich Plasma (PRP) for Facial and Hand Skin Rejuvenation
NCT ID: NCT03647917
Last Updated: 2021-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
12 participants
INTERVENTIONAL
2019-06-18
2021-06-07
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Platelet Rich Plasma, Left face and hands
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.
Platelet Rich Plasma
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 Plasma, Right face and hands
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.
Platelet Rich Plasma
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.
Interventions
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Platelet Rich Plasma
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 Plasma
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.
Eligibility Criteria
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Inclusion Criteria
2. Patients must be 45 years of age or older
3. 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).
4. Patients must have been on stable birth control for the past 6 months if able to conceive
5. Patients are able and willing to provide written informed consent after the study is fully explained
Exclusion Criteria
2. Patients who have had any cosmetic procedures meant to address skin aging of face and hands 3 months prior to enrollment
3. Patients who have had resurfacing laser on face or hands within one year prior to enrollment
4. Patients taking anti-rheumatic disease medication (including methotrexate or other anti-metabolites) within the 3 months prior to study entry
5. Patients who are pregnant or currently breast-feeding
6. Patients with systemic, rheumatic, or inflammatory disease or who are immunosuppressed
7. Patients with ongoing infectious disease, including HIV and hepatitis
8. Patients with history of significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes
9. Patients participating in a study of an experimental drug or medical device within 30 days of study entry
10. Patients with history of platelet disorders, bone marrow aplasia, sepsis, or cancer
11. Patients taking anti-aggregating therapy
12. Patients on anticoagulant therapy
13. Patients with history of keloid formation
14. Patients with uncontrolled diabetes
15. Patients with active skin disease or skin infection on the intended treatment areas, at baseline
45 Years
FEMALE
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Alison J. Bruce
Principal Investigator
Principal Investigators
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Alison J Bruce, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Thais P Pincelli, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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17-005431
Identifier Type: -
Identifier Source: org_study_id