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)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000969268

Enrollment

Registered

2009-11-09

Start date

2007-03-23

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

30 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. severe nasolabial folds 2. No other anti-wrinkle treatment in NLF/mouth region for study duration 3. No history of non-ablative resurfacing procedures, dermabrasion, face-lift, photorejuvenation tehniques, or other surgical procedures in lower 2/3 of face & neck

Exclusion criteria

1. Permanent or semi-permanent implants in lower 2/3 of face 2. Facial hair, lesions, inflammation, infection or visual scars in treatment area 3. History of connective tissue disease 4. Pregnant or breast-feeding

Outcome results