Overview

This trial is active, not recruiting.

Condition photoaging
Treatments harvest prp separation system, sterile saline injection
Phase phase 1/phase 2
Sponsor Northwestern University
Start date May 2011
End date November 2016
Trial size 23 participants
Trial identifier NCT01372566, STU34547

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(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).
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.
(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.
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.

Primary Outcomes

Measure
Primary Outcome Study Part 1: Safety and Tolerability
time frame: 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
time frame: Treatment visit, 2 weeks, 3 months and 6 months

Secondary Outcomes

Measure
Secondary Outcome of Study Part 1: Histologic analysis
time frame: 1 month
Secondary Outcome Study Part 2: Self-Assessment
time frame: 3 and 6 months
Secondary Outcome Study Part 2: Subject Satisfaction
time frame: 6 months
Secondary Outcome Study Part 2: Rate of Adverse Events
time frame: 2 weeks, 3 months, 6 months, 12 months

Eligibility Criteria

Male or female participants from 35 years up to 60 years old.

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.

Additional Information

Official title Effect of Autologous Platelet-rich Plasma on Photoaged Skin: A Prospective Randomized Controlled Trial (Phases A and B)
Principal investigator Murad Alam, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Northwestern University.