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

NCT03647917 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 17-005431
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Aging of Face and Hands

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Secondary Outcomes (1)

• Hand Grading Scale

  24 weeks

Study Arms (2)

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.

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.

Biological: Platelet Rich Plasma

Interventions

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.

Platelet Rich Plasma, Left face and hands

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Alison J Bruce, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Thais P Pincelli, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: August 27, 2018
• Study Start: June 18, 2019
• Primary Completion: June 7, 2021
• Study Completion: June 7, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)