Wrinkle Injection With Autologous Platelet Rich Plasma Study (WIPES)

September 23, 2016 updated by: Novena Medical Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 307506
        • Life Source Medical Centre @ Novena Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effect / Adverse Event
Time Frame: 3 months
Side Effects / Adverse Events to be monitored include allergic reaction, nerve injury and cavernous sinus thrombosis.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novena Medical Center

Investigators

  • Principal Investigator: Kok Leong Tan, MBBS, Life Source Medical Centre @ Novena Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

February 27, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

September 26, 2016

Last Update Submitted That Met QC Criteria

September 23, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTC1000031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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