NCT01078493

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

September 26, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

February 27, 2010

Last Update Submit

September 23, 2016

Conditions

Wrinkles

Keywords

Platelet rich plasmaPRPwrinklesMyCells®CREATELife Source Medical CentreDr Tan Kok leong

Outcome Measures

Primary Outcomes (1)

  • Total Wrinkle Length

    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 Outcomes (1)

  • Side effect / Adverse Event

    3 months

Interventions

MyCells® (injection of platelet rich plasma)DEVICE

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

Also known as: MyCells autologous platelet preparation system

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Life Source Medical Centre @ Novena Medical Center

Singapore, Singapore, 307506, Singapore

Location

Study Officials

  • Kok Leong Tan, MBBS

    Life Source Medical Centre @ Novena Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK

Study Record Dates

First Submitted

February 27, 2010

First Posted

March 2, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2012

Study Completion

May 1, 2012

Last Updated

September 26, 2016

Record last verified: 2016-09

Locations

SG(1)