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Wrinkle Injection With Autologous Platelet Rich Plasma Study (WIPES)

This study has been terminated.
(Protocol revision necessary.)
Sponsor:
Information provided by:
Novena Medical Center
ClinicalTrials.gov Identifier:
NCT01078493
First received: February 27, 2010
Last updated: July 16, 2010
Last verified: July 2010
History of Changes

February 27, 2010
July 16, 2010
February 2010
February 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01078493 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Wrinkle Injection With Autologous Platelet Rich Plasma Study
Phase 1 Study of Intradermal Injection of Autologous Platelet Rich Plasma for Facial Wrinkles

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.

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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Wrinkles
Device: MyCells® (injection of platelet rich plasma)
PRP contains at least 1,000,000 platelets per mm3 or 2-6 times the native concentration of whole blood at a pH of 6.5 to 6.7
Other Name: MyCells autologous platelet preparation system
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
May 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults more than 21 years of age
  • Dis-satisfied or anxious about facial wrinkles (total wrinkle length more than 1cm)

Exclusion Criteria:

  • Pregnant women.
  • Psychiatric patients.
  • Known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia
  • Anticoagulants(eg.aspirin, warfarin)
  • Had other wrinkle therapy for less than a month.(laser, peels, injections)
  • Had facelift surgery for less than a year.
  • Diseased states such as organ failure, severe anaemia, cancer, acute/chronic infections.
  • Involved in personal litigation against an aesthetic service provider
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01078493
CTC1000031
No
Dr Tan Kok Leong, Life Source Medical Centre @ Novena Medical Center
Novena Medical Center
Not Provided
Principal Investigator: Kok Leong Tan, MBBS Life Source Medical Centre @ Novena Medical Center
Novena Medical Center
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP