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

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ClinicalTrials.gov Identifier: NCT03647917
Recruitment Status : Not yet recruiting
First Posted : August 27, 2018
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Alison J. Bruce, Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Skin Aging of Face and Hands Biological: Platelet Rich Plasma Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Aging

Arm Intervention/treatment
Experimental: 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.

Biological: 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.


Experimental: 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.

Biological: 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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hand Grading Scale [ Time Frame: 24 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Only female patients are eligible
  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

  1. Patients with clinically abnormal platelet count, serum chemistry, or screening laboratory results as reviewed by the Principal Investigator
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647917


Contacts
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Contact: Jessica Thompson 904-953-3343 thompson.jessica1@mayo.edu

Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Alison J Bruce Mayo Clinic

Additional Information:
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Responsible Party: Alison J. Bruce, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03647917     History of Changes
Other Study ID Numbers: 17-005431
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No