Wrinkle Injection With Autologous Platelet Rich Plasma Study

NCT ID: NCT01078493

Last Updated: 2016-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Wrinkles

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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MyCells autologous platelet preparation system

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novena Medical Center

NETWORK

Sponsor Role lead

Responsible Party

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Life Source Medical Centre @ Novena Medical Center

Principal Investigators

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Kok Leong Tan, MBBS

Role: PRINCIPAL_INVESTIGATOR

Life Source Medical Centre @ Novena Medical Center

Locations

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Life Source Medical Centre @ Novena Medical Center

Singapore, Singapore, Singapore

Site Status

Countries

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Singapore

Other Identifiers

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CTC1000031

Identifier Type: -

Identifier Source: org_study_id

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