The effectiveness and safety of two dermal fillers (Juvederm Ultra Plus versus Restylane Perlane) in the treatment of patients with severe nasolabial folds.
Comparative Effectiveness and Safety of Juvederm Ultra Plus vs. Restylane Perlane in the Treatment of Subjects with Severe Nasolabial Folds. Phase I and Phase II (Long Term Extension Phase)
Allergan Australia
75 participants
Mar 23, 2007
Interventional
Conditions
Summary
The primary purpose of this study is to determine whether the differences in the product characteristics of 2 commercially available hyaluronic acid (HA)-based dermal fillers translate to differences in their long term durability in patients with severe age-related nasolabial folds (NLFs), following a single administration.
Eligibility
Inclusion Criteria3
- severe nasolabial folds
- No other anti-wrinkle treatment in NLF/mouth region for study duration
- No history of non-ablative resurfacing procedures, dermabrasion, face-lift, photorejuvenation tehniques, or other surgical procedures in lower 2/3 of face & neck
Exclusion Criteria4
- Permanent or semi-permanent implants in lower 2/3 of face
- Facial hair, lesions, inflammation, infection or visual scars in treatment area
- History of connective tissue disease
- Pregnant or breast-feeding
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Juvederm Ultra Plus (hyaluronic acid-based dermal filler) administered by injection directly into the nasolabial fold (NLF) as a single treatment. Up to 2 syringes can be administered to correct the volume deficit in the allocated NLF, with each syringe containing a volume of 0.8 ml. The concentration of hyaluronic acid in each syringe is 24 mg/ml.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12609000969268