Effect of Platelet Rich Plasma on Photoaged Skin

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Autologous Platelet-rich Plasma on Photoaged Skin: A Prospective Randomized Controlled Trial (Phases A and B)

Conditions
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Photoaging

Intervention / Treatment
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* Device: Harvest PRP Separation System
* Other: Sterile Saline injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet Rich Plasma<br>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<br>* 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.<br>|
| Placebo Comparator: Sterile Saline<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 2 weeks, 3 months, 6 months, 12 months |