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Trial registered on ANZCTR


Registration number
ACTRN12609000969268
Ethics application status
Approved
Date submitted
4/11/2009
Date registered
9/11/2009
Date last updated
17/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness and safety of two dermal fillers (Juvederm Ultra Plus versus Restylane Perlane) in the treatment of patients with severe nasolabial folds.
Scientific title
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)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related prominence of nasolabial folds 243875 0
Condition category
Condition code
Skin 252046 252046 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 241493 0
Treatment: Other
Comparator / control treatment
Restylane Perlane (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 1.0 ml. The concentration of hyaluronic acid in each syringe is 20 mg/ml.
Control group
Active

Outcomes
Primary outcome [1] 252948 0
Change in Nasolabial fold (NLF) severity from baseline for the 2 treatment groups, based on the validated Wrinkle Assessment Scale (investigator evaluation)
Timepoint [1] 252948 0
Month 9 post-treatment
Secondary outcome [1] 257679 0
Change in Nasolabial fold (NLF) severity from baseline for the 2 treatment groups at based on the validated Wrinkle Assessment Scale (investigator evaluation)
Timepoint [1] 257679 0
Days 3 & 7; Months 1, 3, 6, 12 & 24 post-treatment
Secondary outcome [2] 257680 0
Change in Nasolabial fold (NLF) severity from baseline for the 2 treatment groups at based on the validated Wrinkle Assessment Scale (patient evaluation)
Timepoint [2] 257680 0
Days 3 & 7; Months 1, 3, 6, 9 & 12 post-treatment
Secondary outcome [3] 262101 0
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)
Timepoint [3] 262101 0
Month 12 post-treatment
Secondary outcome [4] 262103 0
Injection site reactions (investigator & patient evaluation) e.g. bruising, swelling or pain
Timepoint [4] 262103 0
Days 1-3 post-treatment (patients)
Days 3 & 7 post-treatment (investigators)

Eligibility
Key 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
Minimum age
30 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients will receive both treatments in either their left or right NLF. Right NLF will be randomly assigned to receive either Juvederm Ultra Plus or Restylane Perlane, with alternate treatment administered into the left NLF. The randomisation will be facilitated using computer-generated treatment assignments provided to each investigational site in sealed envelopes. As commercial products will be used, it is not possible to blind the investigator injectors/evaluators to the treatment allocations. The patients are required to wear a blindfold and thus they will not be aware of the treatments injected into their NLFs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243957 0
Commercial sector/Industry
Name [1] 243957 0
Allergan Australia
Address [1] 243957 0
Level 4,
810 Pacific Highway
Gordon NSW 2072
Country [1] 243957 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Allergan Australia
Address
Level 4,
810 Pacific Highway
Gordon NSW 2072
Country
Australia
Secondary sponsor category [1] 251313 0
None
Name [1] 251313 0
Address [1] 251313 0
Country [1] 251313 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244069 0
Bellberry Ltd
Ethics committee address [1] 244069 0
229 Greenhill Road
Dulwich SA 5065
Ethics committee country [1] 244069 0
Australia
Date submitted for ethics approval [1] 244069 0
Approval date [1] 244069 0
11/01/2007
Ethics approval number [1] 244069 0
JVD0605

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30306 0
Address 30306 0
Country 30306 0
Phone 30306 0
Fax 30306 0
Email 30306 0
Contact person for public queries
Name 13553 0
Michael Halstead
Address 13553 0
Allergan Australia
Level 4
810 Pacific Highway
Gordon NSW 2072
Country 13553 0
Australia
Phone 13553 0
+61 2 94980167
Fax 13553 0
Email 13553 0
halstead_michael@allergan.com
Contact person for scientific queries
Name 4481 0
Michael Halstead
Address 4481 0
Allergan Australia
Level 4
810 Pacific Highway
Gordon NSW 2072
Country 4481 0
Australia
Phone 4481 0
+61 2 94980167
Fax 4481 0
Email 4481 0
halstead_michael@allergan.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary