Status:
COMPLETED
Safety Study of Three Formulations of the Dermal Implant ELAPR
Lead Sponsor:
Elastagen Pty Ltd
Conditions:
Skin Conditions
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is a Phase I study to assess the safety of three formulations of the dermal implant ELAPR.
Detailed Description
A Phase I study to assess the safety of three formulations of the dermal implant ELAPR in healthy subjects.
Eligibility Criteria
Inclusion
- Good general health status
Exclusion
- Clinically significant abnormalities of haematology or biochemistry testing
- Bleeding diathesis, anticoagulant drugs,thrombocytopenia or clinically significant prolonged APTT or PT
- Chronic use of aspirin, other non-steroidal antiinflammatory drugs or other anti-platelet agents
- History of keloid formation
- Systemic corticosteroids within last 12 weeks
- Diabetes or metabolic disorders
- Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication
- Pregnancy/lactation
- A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01467778
Start Date
December 1 2010
End Date
May 1 2011
Last Update
November 9 2011
Active Locations (1)
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1
Woolcock Institute of Medical Research
Glebe, New South Wales, Australia, 2037