Effect of Platelet Rich Plasma on Photoaged Skin

NCT01372566 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: STU34547
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess the safety, tolerability and effectiveness of platelet rich plasma in the treatment of photoaged skin. This study will be divided into two parts. The first part will assess the safety and tolerability of platelet rich plasma injections as compared to sterile saline injections in subjects' arm with six months follow-up. The second part will assess the effect of platelet rich plasma on the appearance of facial skin in a split face study with platelet rich plasma injections on one side of the face and sterile saline on the other. Outcomes will be recorded for twelve months.

Conditions

Photoaging

Outcome Measures

Primary Outcomes (2)

• Primary Outcome Study Part 1: Safety and Tolerability

  The primary outcome measures will be the evaluation of safety and tolerability, which will be assessed by collection of adverse events throughout the feasibility study.

  2 weeks, 1 month, 3 months and 6 months

• Primary Outcome Study Part 2: Change in Photoaging scores from Baseline at 2 weeks, 3 months, and 6 months

  Photoaging scores will be recorded for each cheek by two blinded dermatologists at the treatment visit (before treatment)and during the 2 week, 3 month, and 6 month post-treatment visits. Individual scores for each variable (fine lines, mottled pigmentation, roughness, and sallowness) will be recorded by the blinded dermatologists.

  Treatment visit, 2 weeks, 3 months and 6 months

Secondary Outcomes (4)

• Secondary Outcome of Study Part 1: Histologic analysis

  1 month

• Secondary Outcome Study Part 2: Self-Assessment

  3 and 6 months

• Secondary Outcome Study Part 2: Subject Satisfaction

  6 months

• Secondary Outcome Study Part 2: Rate of Adverse Events

  2 weeks, 3 months, 6 months, 12 months

Study Arms (2)

Platelet Rich Plasma

EXPERIMENTAL

Concentrated blood platelets from subject will be injected multiple times into the superficial layer of either their arm (Part 1) or one side of their upper face and cheek (Part 2).

Device: Harvest PRP Separation System

Sterile Saline

PLACEBO COMPARATOR

Sterile saline will be injected multiple times into the superficial layer of either their arm (Part 1) or one side of their upper face and cheek (Part 2)that has not been injected with PRP.

Other: Sterile Saline injection

Interventions

Harvest PRP Separation System DEVICE

Platelet-rich plasma (PRP) is a blood-derived therapy that consists of platelets and growth factors. PRP can be formed by drawing blood from a vein and spinning it at a high speed in a specialized device called a centrifuge.

Platelet Rich Plasma

Sterile Saline injection OTHER

Sterile Saline will be injected multiple times in a different area of the arm (Part 1) or on the opposite side of the face from where the platelet rich plasma is injected.

Sterile Saline

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Part 1:
• Subjects of either gender (M/F), 35-60 years old.
• Subjects are in good health.
• Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
• Part 2:
• Subjects of either gender (M/F), 35-60 years old.
• Subjects are in good health.
• Bilateral cheek wrinkles "in motion" with severities of ≥ type II of Glogau photoaging classification (APPENDIX I).
• Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
• Subject requests cosmetic improvement of facial wrinkles.

You may not qualify if:

• Pregnant or lactating.
• Subjects who are unable to understand the protocol or to give informed consent.
• Subjects who have a self-reported history of blood or platelet disorders e.g. anemia, thrombocytopenia, coagulopathy, hypofibrinogenemia, or are on anticoagulant or antiplatelet therapy.
• Subjects who have active skin disease or skin infection in treatment area. Subjects who have a history of hypertrophic scars and keloids.
• Subjects who have any requirement for the use of local or systemic steroids or immunosuppressive agents.
• Subject notes that he/she is HIV positive
• Subjects with history of skin cancer or actinic keratosis
• Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
• Skin conditions that interfere with wrinkle assessment/treatment (excessive dermatochalasis, inability to lessen the wrinkles by physically spreading the area apart).
• Excessive exposure to the sun, such as jobs requiring constant outdoor exposure.
• Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, ect.
• Part 2:
• Pregnant or lactating.
• Subjects who are unable to understand the protocol or to give informed consent.
• Subjects who have a history of blood or platelet disorders e.g. anemia, thrombocytopenia, coagulopathy, hypofibrinogenemia, or are on anticoagulant or anti-platelet therapy.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Alam M, Hughart R, Champlain A, Geisler A, Paghdal K, Whiting D, Hammel JA, Maisel A, Rapcan MJ, West DP, Poon E. Effect of Platelet-Rich Plasma Injection for Rejuvenation of Photoaged Facial Skin: A Randomized Clinical Trial. JAMA Dermatol. 2018 Dec 1;154(12):1447-1452. doi: 10.1001/jamadermatol.2018.3977.

  PMID: 30419125 DERIVED

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 14, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

US (1)