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

Early Phase 1
Completed
Conditions
Skin Aging of Face and Hands
Interventions
Biological: Platelet Rich Plasma
Registration Number
NCT03647917
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
12
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Platelet Rich Plasma, Right face and handsPlatelet 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.
Platelet Rich Plasma, Left face and handsPlatelet 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.
Primary Outcome Measures
NameTimeMethod
Wrinkle Severity Rating Scale (WSRS)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
NameTimeMethod
Hand Grading Scale24 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.

Trial Locations

Locations (1)

Mayo Clinic in Florida

🇺🇸

Jacksonville, Florida, United States

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