Wrinkle Injection With Autologous Platelet Rich Plasma Study

Phase 1

Withdrawn

• Conditions: Wrinkles

• Registration Number: NCT01078493
• Lead Sponsor: Novena Medical Center

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-27
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Primary Completion: 2012-02
• Study Completion: 2012-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-23
• Last Update Posted: 2016-09-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total Wrinkle Length	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Life Source Medical Centre @ Novena Medical Center; 🇸🇬 Singapore, Singapore