Wrinkle Injection With Autologous Platelet Rich Plasma Study (WIPES)
Wrinkles result from imperfect repair of the dermal layer resulting in loss of collagen commonly due to ageing, smoking and sun exposure. Platelet rich plasma (PRP) contains a host of growth factors, which have been used in other clinical trials for various medical conditions such as tendonitis, and also in surgery such as the surgical repair of facial defects. Results from these clinical trials suggest that PRP helps in collagen formation and organisation to promote healing of tissues. This study attempts to document the clinical effects of intradermal injection of PRP on wrinkles.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1 Study of Intradermal Injection of Autologous Platelet Rich Plasma for Facial Wrinkles|
- Total Wrinkle Length [ Time Frame: 3 months ] [ Designated as safety issue: No ]All visible wrinkles are measured and the length is summed up to give the Total Wrinkle Length. Comparison of pre treatment and post treatment Total Wrinkle Length will be studied.
- Side effect / Adverse Event [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Side Effects / Adverse Events to be monitored include allergic reaction, nerve injury and cavernous sinus thrombosis.
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||May 2012|
|Estimated Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Device: MyCells® (injection of platelet rich plasma)
10 selected participants will have 10 ml of blood removed for platelet extraction with MyCells®. The resulting Platelet rich plasma will be injected intradermally into the facial wrinkles.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078493
|Life Source Medical Centre @ Novena Medical Center|
|Singapore, Singapore, 307506|
|Principal Investigator:||Kok Leong Tan, MBBS||Life Source Medical Centre @ Novena Medical Center|