A Phase 1/2 interventional study of Harvest PRP Separation System and Sterile Saline injection in Photoaging, sponsored by Northwestern University. Active, not recruiting at 1 site in United States. Open to participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Northwestern University · Phase 1/2, Interventional, and Treatment
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.
Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
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Part 1:
Part 2:
Exclusion Criteria:
Part 2:
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 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
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 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 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.
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
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.
Time frame: Treatment visit, 2 weeks, 3 months and 6 months
Secondary Outcome of Study Part 1: Histologic analysis
The secondary outcomes measures will involve the dermatopathologic review of the 2 skin biopsies taken from each subject at the one month post-treatment visit. One 3mm biopsy will be taken from the skin where the saline was injected and the other from the site of PRP injection. These will be reviewed by the dermatopathologists in the Department of Dermatology for significant histological changes, including collagen remodeling and possible reduction in photodamage. Histologic stains will include hematoxylin and eosin and Masson's trichrome.
Time frame: 1 month
Secondary Outcome Study Part 2: Self-Assessment
A subject self-assessment of each cheek will be performed at the 3 and 6 month follow up visits.
Time frame: 3 and 6 months
Secondary Outcome Study Part 2: Subject Satisfaction
A subject overall satisfaction questionnaire will be performed at the 6 month follow up visit.
Time frame: 6 months
Secondary Outcome Study Part 2: Rate of Adverse Events
Adverse events will be recorded at each time point, if they occur. Statitical analysis will determine the rate of any adverse events between PRP and Saline.
Time frame: 2 weeks, 3 months, 6 months, 12 months
This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Northwestern University