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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01463657




Trial ID
NCT01463657
Ethics application status
Date submitted
18/09/2011
Date registered
30/10/2011
Date last updated
22/01/2013

Titles & IDs
Public title
Split-face Comparison Study to Assess ELAPR Compared to Juvéderm® for the Treatment of Nasolabial Folds
Scientific title
A Phase 2 Bilateral (Split-face) Comparison Study to Assess Two Formulations of ELAPR Compared to Juvéderm® Ultra Plus for the Treatment of Moderate to Severe Nasolabial Folds
Secondary ID [1] 0 0
ELAPR P2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aging 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Juvéderm® Ultra Plus
Treatment: Devices - ELAPR002

Experimental: ELAPR002 - Each treatment will consist of up 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each NLF using a 27G needle. The needle will be inserted at an approximate angle of 30o parallel to the skin, and the product may be injected by a retrograde injection or by deposition of a bolus. ELAPR and the control may be implanted parallel or perpendicular to the NLF. Exactly the same technique will be used for the treatment of both NLFs for each patient.

Active Comparator: Juvéderm® Ultra Plus - Each treatment will consist of up 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each NLF using a 27G needle. The needle will be inserted at an approximate angle of 30o parallel to the skin, and the product may be injected by a retrograde injection or by deposition of a bolus. ELAPR and the control may be implanted parallel or perpendicular to the NLF. Exactly the same technique will be used for the treatment of both NLFs for each patient.


Treatment: Devices: Juvéderm® Ultra Plus
Patients will receive either ELAPR002b or ELAPR002d for the treatment of one NLF, and Juvéderm® Ultra Plus for the treatment of the second, opposite NLF. Treatments will be provided on Day 1 and repeated on Day 29 (if required at the discretion of the investigator) Day 57 (if required at the discretion of the investigator)to achieve OCR.

Treatment: Devices: ELAPR002
Each treatment will consist of up 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each NLF using a 27G needle. The needle will be inserted at an approximate angle of 30o parallel to the skin, and the product may be injected by a retrograde injection or by deposition of a bolus. ELAPR and the control may be implanted parallel or perpendicular to the NLF. Exactly the same technique will be used for the treatment of both NLFs for each patient.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess the effect of two formulations of ELAPR on change from baseline of the severity of the Nasolabial folds against a Wrinkle Assessment Scale of Nasolabial folds score at 24 weeks vs. active control - The primary efficacy variable is the change in Wrinkle Assessment Scale (WAS). The values for WAS recorded at each visit will be summarized by treatment.
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Assess the acute safety of ELAPR - Adverse event profile will be collected.
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Assess chronic safety of ELAPR - A serum sample will be collected at Day 1, 29, 85, and Day 169, or at the completion visit in the event of early withdrawal or early termination and stored for a maximum of 5 years for the development of an assay to measure circulating anti-tropoelastin antibody levels.
Timepoint [2] 0 0
24 weeks

Eligibility
Key inclusion criteria
- Aged 25 - 65 years

- Male or Female

- Moderate to severe NLFs scored equally as a 3 or 4 out of 5 on both sides of the face
using the WAS scale

- Good general health status

- Able to give informed consent
Minimum age
25 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Clinically significant abnormalities of haematology or biochemistry testing

- Bleeding diathesis, anticoagulant drugs, thrombocytopenia or clinically significant
prolonged bleeding time

- Chronic use of aspirin, other non-steroidal anti-inflammatory drugs or other
anti-platelet agents

- Allergy to local anaesthetics

- Active infection at the treatment site

- Treatment of either NLF other than with a hyaluronic acid (HA) dermal filler and
treatment with a HA dermal filler within 18 months of enrolment

- Any serious medical condition which in the opinion of the investigator would have a
strong possibility of requiring systemic corticosteroid medication

- Pregnancy/lactation

- History of keloid formation

- Systemic corticosteroids within last 12 weeks

- Diabetes or metabolic disorders

- A history of anaphylaxis or allergic reactions including any known hypersensitivity to
Hyaluronic acid or lidocaine

- Sensitivity to Juvéderm® Ultra Plus or Juvéderm® products.

- Participation in any other clinical trial one month prior to treatment and for the
duration of the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
QLD,VIC
Recruitment hospital [1] 0 0
Cosmedic - Southport
Recruitment hospital [2] 0 0
Dermatology Institute of Victoria - Melbourne
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
3141 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Elastagen Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Patients presenting to the clinic for treatment of moderate to severe Nasolabial folds will
be recruited to receive either ELAPR002b or ELAPR002d for the treatment of one Nasolabial
fold and Juvéderm® Ultra Plus for the treatment of the second, opposite Nasolabial fold.
Trial website
https://clinicaltrials.gov/show/NCT01463657
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Greg Goodman, MBBS FRACS
Address 0 0
Dermatology Institute of Victoria
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries