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

Elastagen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Aging

Treatments: Device: ELAPR002; Device: Juvéderm® Ultra Plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01463657

ELAPR P2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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30 participants in 2 patient groups

ELAPR002

Experimental group

Description:

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:

Device: ELAPR002

Juvéderm® Ultra Plus

Active Comparator group

Description:

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:

Device: Juvéderm® Ultra Plus