Effect of Platelet Rich Plasma on Photoaged Skin

Phase 1

Active, not recruiting

• Conditions: Photoaging
• Interventions: Device: Harvest PRP Separation System; Other: Sterile Saline injection

• Registration Number: NCT01372566
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-01
• Study First Submitted QC: 2011-06-10
• Study First Posted: 2011-06-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 23

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Platelet Rich Plasma	Harvest PRP Separation System	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).
Sterile Saline	Sterile Saline injection	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.

Primary Outcome Measures

Name	Time	Method
Primary Outcome Study Part 2: Change in Photoaging scores from Baseline at 2 weeks, 3 months, and 6 months	Treatment visit, 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.
Primary Outcome Study Part 1: Safety and Tolerability	2 weeks, 1 month, 3 months and 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome Study Part 2: Subject Satisfaction	6 months	A subject overall satisfaction questionnaire will be performed at the 6 month follow up visit.
Secondary Outcome of Study Part 1: Histologic analysis	1 month	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.
Secondary Outcome Study Part 2: Self-Assessment	3 and 6 months	A subject self-assessment of each cheek will be performed at the 3 and 6 month follow up visits.
Secondary Outcome Study Part 2: Rate of Adverse Events	2 weeks, 3 months, 6 months, 12 months	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.

Trial Locations

Locations (1)

Northwestern University Dermatology; 🇺🇸 Chicago, Illinois, United States