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

NCT01463657 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-01-24

No results posted yet for this study

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® Ultra Plus for the treatment of the second, opposite Nasolabial fold.

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.

Sponsors & Collaborators

  • Elastagen Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Greg Goodman, MBBS FRACS · Dermatology Institute of Victoria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01463657 on ClinicalTrials.gov