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

NCT01463657 | Completed Phase 1

• 1 other identifier: ELAPR P2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Aging

Keywords

Aging

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Secondary Outcomes (2)

• Assess the acute safety of ELAPR

  24 weeks

• Assess chronic safety of ELAPR

  24 weeks

Study Arms (2)

ELAPR002

EXPERIMENTAL

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

Juvéderm® Ultra Plus

ACTIVE COMPARATOR

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

Interventions

Juvéderm® Ultra Plus DEVICE

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.

Juvéderm® Ultra Plus

ELAPR002 DEVICE

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.

Also known as: Tropelastin

ELAPR002

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elastagen Pty Ltd: lead

Study Sites (2)

Cosmedic

Southport, Queensland, 4215, Australia

Location

Dermatology Institute of Victoria

Melbourne, Victoria, 3141, Australia

Location

Study Officials

• Greg Goodman, MBBS FRACS

  Dermatology Institute of Victoria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2011
• First Posted: November 2, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

AU (2)