Wrinkle Injection With Autologous Platelet Rich Plasma Study (WIPES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01078493
Recruitment Status : Withdrawn (Protocol revision necessary.)
First Posted : March 2, 2010
Last Update Posted : September 26, 2016
Information provided by:
Novena Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Wrinkles Device: MyCells® (injection of platelet rich plasma) Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Intradermal Injection of Autologous Platelet Rich Plasma for Facial Wrinkles
Study Start Date : February 2010
Primary Completion Date : February 2012
Study Completion Date : May 2012

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

Primary Outcome Measures :
  1. Total Wrinkle Length [ Time Frame: 3 months ]
    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 :
  1. Side effect / Adverse Event [ Time Frame: 3 months ]
    Side Effects / Adverse Events to be monitored include allergic reaction, nerve injury and cavernous sinus thrombosis.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01078493

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

Responsible Party: Dr Tan Kok Leong, Life Source Medical Centre @ Novena Medical Center Identifier: NCT01078493     History of Changes
Other Study ID Numbers: CTC1000031
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016

Keywords provided by Novena Medical Center:
Platelet rich plasma
Life Source Medical Centre
Dr Tan Kok leong