Wrinkle Injection With Autologous Platelet Rich Plasma Study

Wrinkles Clinical Trial

— WIPES  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01078493
• Other study ID #: CTC1000031
• Status: Withdrawn
• Phase: Phase 1
• First received: February 27, 2010
• Last updated: September 23, 2016
• Start date: February 2010
• Est. completion date: May 2012

Study information

• Verified date: September 2016
• Source: Novena Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wrinkles

Intervention

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

Locations

Country	Name	City	State
Singapore	Life Source Medical Centre @ Novena Medical Center	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Novena Medical Center

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Side effect / Adverse Event	Side Effects / Adverse Events to be monitored include allergic reaction, nerve injury and cavernous sinus thrombosis.	3 months	Yes