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Completed

NCT Number: NCT03647917

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

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.

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Key information

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Platelet rich plasma

Biological

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: PRP

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 27, 2018
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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