Status:
COMPLETED
Split-face Comparison Study to Assess ELAPR Compared to Juvéderm® for the Treatment of Nasolabial Folds
Lead Sponsor:
Elastagen Pty Ltd
Conditions:
Aging
Eligibility:
All Genders
25-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Patients presenting to the clinic for treatment of moderate to severe Nasolabial folds will be recruited to receive either ELAPR002b or ELAPR002d for the treatment of one Nasolabial fold and Juvéderm®...
Detailed Description
The treatment will be repeated on Day 29 (if required) and Day 57 (if required) to achieve optimum cosmetic results (OCR). Each treatment will consist of up to 15 injections in total, each consisting...
Eligibility Criteria
Inclusion
- Aged 25 - 65 years
- Male or Female
- Moderate to severe NLFs scored equally as a 3 or 4 out of 5 on both sides of the face using the WAS scale
- Good general health status
- Able to give informed consent
Exclusion
- Clinically significant abnormalities of haematology or biochemistry testing
- Bleeding diathesis, anticoagulant drugs, thrombocytopenia or clinically significant prolonged bleeding time
- Chronic use of aspirin, other non-steroidal anti-inflammatory drugs or other anti-platelet agents
- Allergy to local anaesthetics
- Active infection at the treatment site
- Treatment of either NLF other than with a hyaluronic acid (HA) dermal filler and treatment with a HA dermal filler within 18 months of enrolment
- Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication
- Pregnancy/lactation
- History of keloid formation
- Systemic corticosteroids within last 12 weeks
- Diabetes or metabolic disorders
- A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine
- Sensitivity to Juvéderm® Ultra Plus or Juvéderm® products.
- Participation in any other clinical trial one month prior to treatment and for the duration of the study.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01463657
Start Date
November 1 2011
End Date
December 1 2012
Last Update
January 24 2013
Active Locations (2)
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1
Cosmedic
Southport, Queensland, Australia, 4215
2
Dermatology Institute of Victoria
Melbourne, Victoria, Australia, 3141