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

Aging Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463657
• Other study ID #: ELAPR P2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 18, 2011
• Last updated: January 22, 2013
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Elastagen Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Aging

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	Dermatology Institute of Victoria	Melbourne	Victoria
Australia	Cosmedic	Southport	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Elastagen Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Assess the acute safety of ELAPR	Adverse event profile will be collected.	24 weeks	Yes
Secondary	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.	24 weeks	Yes