Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upper Arm Dermis

NCT01466413 | Completed Phase 1

• 1 other identifier: ELAPR P1B
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is an early phase study comparing two fixed dose of the study compound ELAPR and a Restylane® Vital Light (control), by multiple intradermal injections to a 3cm x 3cm area of the upper arm dermis. All subjects will receive three treatments, 3 weeks apart. Each treatment will consist of 16 injections in total, each 10mm apart in a grid formation over a 3cm x 3cm area of the mid - to deep dermis of the medial aspect of the upper arm. Each injection will consist of 20-30ul of product delivered using a 30Gx¼" needle.

Conditions

Intrinsic Aging of Skin

Keywords

Intrinsic Aging of Skin

Outcome Measures

Primary Outcomes (1)

• Assess the persistence and tissue compatibility with histopathology.

  A 4mm skin biopsy will be taken from each of the implant sites from Cohort A subjects on Day 169, and from Cohort B subjects on Day 85.

  26 weeks

Secondary Outcomes (1)

• Assess the acute and chronic safety of ELAPR.

  26 weeks

Study Arms (1)

Restylane

EXPERIMENTAL

Patients with an even subject identification number (SIN) (02, 04, 06, 08, 10, 12, 14, 16) will have ELAPR to the right arm and the control to the left, where patients with an odd subject identification number (01, 03, 05, 07, 09, 11, 13, 15) will have the ELAPR to the left arm and the control to the right. Patients will receive either device ELAPR002c or ELAPR002e. This will alternate to minimise bias between the right and left arms. The first group of eight patients (01 - 08) will have their biopsy performed at day 169. The second group of eight patients (09 - 16) will have their biopsy at day 85.

Device: Tropoelastin

Interventions

Tropoelastin DEVICE

Multiple intradermal implants comprising of three treatments, 3 weeks apart, each consisting of 16 injections in total, each 10mm apart in a grid formation over a 3cm x 3cm area of the mid to deep dermis of the medial aspect of the upper arm. Each injection will consist of 20-30ul of product delivered using a 30Gx¼" needle. Each subject will also receive Restylane® Vital Light (control) to the opposite arm following the same treatment regimen and using the same technique. The treatment will be administered on Day 1, 22 and 43.

Also known as: Restylane Vital Light

Restylane

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 35 to 50 years
• Male or Female
• 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 APTT or PT
• Chronic use of aspirin, other non-steroidal anti-inflammatory drugs or other anti-platelet agents
• History of keloid formation
• Systemic corticosteroids within last 12 weeks
• Diabetes or other metabolic disorders that may interfere with the subject's response to treatment in the opinion of the investigator
• Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication
• Pregnancy/lactation
• Previously received Tropoelastin
• A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine
• Sensitivity to Restylane® Vital light or Restylane products
• Use of any other investigational product on the intended implant site in the previous 12 months.
• Sensitivity to topical local anaesthetic cream (EMLA®) or have the following conditions where EMLA is contraindicated: dermatitis, Methaemoglobinaemia, Glucose-6-phosphate dehydrogenase deficiency or "Mollusca Contagiosa"

Sponsors & Collaborators

• Elastagen Pty Ltd: lead

Study Sites (1)

Woolcock Institute of Medical Research

Glebe, New South Wales, 2050, Australia

Location

Study Officials

• Carlos China, MBBS

  Woolcock Institute Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 18, 2011
• First Posted: November 8, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 15, 2012

Record last verified: 2012-10

Locations

AU (1)