Wrinkle Injection With Autologous Platelet Rich Plasma Study | NCT01078493

Studies
Wrinkle Injection With Autologous Platelet Rich Plasma Study

NCT01078493

Sponsor

Novena Medical Center

Status

Withdrawn

Last Update Posted

Sep 26, 2016Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Wrinkles

Interventions

MyCells® (injection of platelet rich plasma)

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Protocol revision necessary.

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Feb 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Feb 27, 2010

First Submission Date that Met QC Criteria

Mar 1, 2010

First Posted Date

Mar 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2016

Last Update Posted Date

Sep 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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		MyCells autologous platelet preparation system

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kok Leong Tan, MBBS	Life Source Medical Centre @ Novena Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Life Source Medical Centre @ Novena Medical Center		Singapore	Singapore	307506	Singapore