Effect of Platelet Rich Plasma on Photoaged Skin

NCT ID: NCT01372566

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Platelet Rich Plasma

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).

Group Type: EXPERIMENTAL

Harvest PRP Separation System

Intervention Type: 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.

Sterile Saline

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.

Group Type: PLACEBO_COMPARATOR

Sterile Saline injection

Intervention Type: 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.

Interventions

Harvest PRP Separation System

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.

Intervention Type: DEVICE

Sterile Saline injection

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• 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.
• Subjects who have had topical or oral tretinoin, chemical peeling, botulinum toxin injection or laser and light treatment for facial rhytides or rejuvenation within past 6 months or planning to undergo treatments as described in the next 3 months.
• Facial surgery in the lower 2/3 of the face or semi-permanent dermal fillers within 1 year prior to study enrollment
• Subjects who have history of recurrent facial or labial herpes simplex infection.
• Subjects who have active skin disease or skin infection in treatment area.
• Subjects who are allergic to lidocaine or prilocaine.
• 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Murad Alam

Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Dermatology

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30419125 (View on PubMed)

Other Identifiers

STU34547

Identifier Type: -

Identifier Source: org_study_id