Split-face Comparison Study to Assess ELAPR Compared to Juvéderm® for the Treatment of Nasolabial Folds

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Aging
Interventions
DEVICE

Juvéderm® Ultra Plus

Patients will receive either ELAPR002b or ELAPR002d for the treatment of one NLF, and Juvéderm® Ultra Plus for the treatment of the second, opposite NLF. Treatments will be provided on Day 1 and repeated on Day 29 (if required at the discretion of the investigator) Day 57 (if required at the discretion of the investigator)to achieve OCR.

DEVICE

ELAPR002

Each treatment will consist of up 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each NLF using a 27G needle. The needle will be inserted at an approximate angle of 30o parallel to the skin, and the product may be injected by a retrograde injection or by deposition of a bolus. ELAPR and the control may be implanted parallel or perpendicular to the NLF. Exactly the same technique will be used for the treatment of both NLFs for each patient.

Trial Locations (2)

3141

Dermatology Institute of Victoria, Melbourne

4215

Cosmedic, Southport

All Listed Sponsors
lead

Elastagen Pty Ltd

INDUSTRY

NCT01463657 - Split-face Comparison Study to Assess ELAPR Compared to Juvéderm® for the Treatment of Nasolabial Folds | Biotech Hunter | Biotech Hunter