ActivePhase 4ACTRN12609000969268

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)

Sponsor

Allergan Australia

Enrollment

75 participants

Start Date

Mar 23, 2007

Study Type

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

Sex: Both males and femalesMin Age: 30 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two popular dermal filler products for treating deep lines running from the nose to the corners of the mouth (nasolabial folds). It is for adults aged 30 and over with severe nasolabial folds who have not had facial implants or recent cosmetic procedures in the lower face.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Australia

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ACTRN12609000969268