Effect of Platelet Rich Plasma on Photoaged Skin | NCT01372566

NCT01372566

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Platelet Rich Plasma	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).	Device: Harvest PRP Separation System
Sterile Saline	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.	Other: Sterile Saline injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Harvest PRP Separation System	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.

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Eligibility Module

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.

Type	Date	Date Unknown
Release	May 5, 2025
Reset	May 23, 2025