Split-face Comparison Study to Assess ELAPR Compared to Juvéderm® for the Treatment of Nasolabial Folds - Full Text View

Purpose

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.

Condition	Intervention	Phase
Aging	Device: Juvéderm® Ultra Plus Device: ELAPR002	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official 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

Further study details as provided by Elastagen Pty Ltd:

Primary Outcome Measures:

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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Assess the acute safety of ELAPR [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Adverse event profile will be collected.
Assess chronic safety of ELAPR [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	30
Study Start Date:	November 2011
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Device: 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. Other Name: Tropelastin
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.	Device: 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. Other Name: Juvéderm® Ultra Plus

Arms

Assigned Interventions

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.

Device: 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.

Other Name: Tropelastin

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.

Device: 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.

Other Name: Juvéderm® Ultra Plus

Detailed Description:

The treatment will be repeated on Day 29 (if required) and Day 57 (if required) to achieve optimum cosmetic results (OCR).

Each treatment will consist of up to 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 Nasolabial fold using a 27G needle.

Each patient will receive the same preparation implanted as a bolus of 0.1mL at Day 1 into the mid-deep dermis of the skin of the medial aspect of the upper arm using a 27G needle, and two 2mm biopsies will be taken at the same visit on Day 57, Day 85 or Day 169 depending on randomisation for histopathology assessment.

Eligibility

Ages Eligible for Study:	25 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463657

Locations

Australia, Queensland
Cosmedic
Southport, Queensland, Australia, 4215
Australia, Victoria
Dermatology Institute of Victoria
Melbourne, Victoria, Australia, 3141

Sponsors and Collaborators

Elastagen Pty Ltd

Investigators

Principal Investigator:

Greg Goodman, MBBS FRACS

Dermatology Institute of Victoria

More Information

No publications provided

Responsible Party:	Elastagen Pty Ltd
ClinicalTrials.gov Identifier:	NCT01463657 History of Changes
Other Study ID Numbers:	ELAPR P2
Study First Received:	September 18, 2011
Last Updated:	January 22, 2013
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by Elastagen Pty Ltd:

Aging

ClinicalTrials.gov processed this record on May 23, 2013