The effectiveness and safety of two dermal fillers (Juvederm Ultra Plus versus Restylane Perlane) in the treatment of patients with severe nasolabial folds.

Phase 4

Active, not recruiting

• Conditions: Age-related prominence of nasolabial folds; Skin - Dermatological conditions

• Registration Number: ACTRN12609000969268
• Lead Sponsor: Allergan Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Nasolabial fold (NLF) severity from baseline for the 2 treatment groups, based on the validated Wrinkle Assessment Scale (investigator evaluation)[Month 9 post-treatment]

Secondary Outcome Measures

Name	Time	Method
Change in Nasolabial fold (NLF) severity from baseline for the 2 treatment groups at based on the validated Wrinkle Assessment Scale (investigator evaluation)[Days 3 & 7; Months 1, 3, 6, 12 & 24 post-treatment];Change in Nasolabial fold (NLF) severity from baseline for the 2 treatment groups at based on the validated Wrinkle Assessment Scale (patient evaluation)[Days 3 & 7; Months 1, 3, 6, 9 & 12 post-treatment];Patient's treatment satisfaction (by checking a box identifying whether they prefer the outcome of the treatment at the right or left NLF or have no preference)[Month 12 post-treatment];Injection site reactions (investigator & patient evaluation) e.g. bruising, swelling or pain[Days 1-3 post-treatment (patients)<br>Days 3 & 7 post-treatment (investigators)]