Effect of Platelet Rich Plasma on Photoaged Skin (NCT01372566) | Clinical Trial Compass
UnknownPhase 1/2
Effect of Platelet Rich Plasma on Photoaged Skin
United States23 participantsStarted 2011-05
Plain-language 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.
Who can participate
Age range
35 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 direc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Outcome Study Part 1: Safety and Tolerability
Timeframe: 2 weeks, 1 month, 3 months and 6 months
2
Primary Outcome Study Part 2: Change in Photoaging scores from Baseline at 2 weeks, 3 months, and 6 months
Timeframe: Treatment visit, 2 weeks, 3 months and 6 months