Effect of Platelet Rich Plasma on Photoaged Skin
|ClinicalTrials.gov Identifier: NCT01372566|
Recruitment Status : Active, not recruiting
First Posted : June 14, 2011
Last Update Posted : March 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Photoaging||Device: Harvest PRP Separation System Other: Sterile Saline injection||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effect of Autologous Platelet-rich Plasma on Photoaged Skin: A Prospective Randomized Controlled Trial (Phases A and B)|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Platelet Rich Plasma
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
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.
Placebo Comparator: Sterile Saline
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
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 [ Time Frame: 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.
- Primary Outcome Study Part 2: Change in Photoaging scores from Baseline at 2 weeks, 3 months, and 6 months [ Time Frame: 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.
- Secondary Outcome of Study Part 1: Histologic analysis [ Time Frame: 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 [ Time Frame: 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: Subject Satisfaction [ Time Frame: 6 months ]A subject overall satisfaction questionnaire will be performed at the 6 month follow up visit.
- Secondary Outcome Study Part 2: Rate of Adverse Events [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372566
|United States, Illinois|
|Northwestern University Dermatology|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Murad Alam, MD||Northwestern University|