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
  Purpose

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.


Condition Intervention Phase
Wrinkles
Device: MyCells® (injection of platelet rich plasma)
Phase 1

Study Type: Interventional
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

Further study details as provided by Novena Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 1
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)
Intervention Details:
    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
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078493

Locations
Singapore
Life Source Medical Centre @ Novena Medical Center
Singapore, Singapore, 307506
Sponsors and Collaborators
Novena Medical Center
Investigators
Principal Investigator: Kok Leong Tan, MBBS Life Source Medical Centre @ Novena Medical Center
  More Information

No publications provided

Responsible Party: Dr Tan Kok Leong, Life Source Medical Centre @ Novena Medical Center
ClinicalTrials.gov Identifier: NCT01078493     History of Changes
Other Study ID Numbers: CTC1000031
Study First Received: February 27, 2010
Last Updated: July 16, 2010
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Novena Medical Center:
Platelet rich plasma
PRP
wrinkles
MyCells®
CREATE
Life Source Medical Centre
Dr Tan Kok leong

ClinicalTrials.gov processed this record on July 23, 2014