Wrinkle Injection With Autologous Platelet Rich Plasma Study

Study Overview
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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.

Official Title
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Phase 1 Study of Intradermal Injection of Autologous Platelet Rich Plasma for Facial Wrinkles

Conditions
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Wrinkles

Intervention / Treatment
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* Device: MyCells® (injection of platelet rich plasma)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet rich plasma, PRP, wrinkles, MyCells®, CREATE, Life Source Medical Centre, Dr Tan Kok leong