Clinical trial NCT03647917: A Pilot Study on the Use of Platelet Rich Plasma (PRP) for Facial and Hand Skin Rejuvenation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Skin Aging of Face and Hands
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 12
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Wrinkle Severity Rating Scale (WSRS)
timeFrame: 24 weeks
Secondary outcomes:
measure: Hand Grading Scale
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Alison J Bruce, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Thais P Pincelli, MD
role: PRINCIPAL_INVESTIGATOR
References: