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

• ClinicalTrials.gov Identifier: NCT01466413
• Recruitment Status: Completed
• First Posted: November 8, 2011
• Last Update Posted: October 15, 2012
• Sponsor: Elastagen Pty Ltd
• Information provided by (Responsible Party): Elastagen Pty Ltd

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Intrinsic Aging of Skin	Device: Tropoelastin	Phase 1

Detailed Description:

Each subject will also receive Restylane® Vital Light (control) to the opposite arm following the same treatment regimen and using the same technique. A 4mm skin biopsy will be taken from each of the implant sites from Cohort A subjects (including replacements) on Day 169, and from Cohort B subjects (including replacements) on Day 85. The biopsy will encompass the needle point tattoo at the centre of the implant site. The biopsy site will be closed with a single stitch followed by standard aftercare procedures with stitch removal 7 to 10 days later.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: A Phase 1B Study to Assess the Safety and Efficacy of Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upper Arm Dermis
• Study Start Date: September 2011
• Actual Primary Completion Date: April 2012
• Actual Study Completion Date: April 2012

Arms and Interventions

Arm

Intervention/treatment

Experimental: Restylane; 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; 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.; Other Name: Restylane Vital Light

Outcome Measures

Primary Outcome Measures :

1. Assess the persistence and tissue compatibility with histopathology. [ Time Frame: 26 weeks ]
   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.

Secondary Outcome Measures :

1. Assess the acute and chronic safety of ELAPR. [ Time Frame: 26 weeks ]
   Biopsy at day 85 or day 169 depending on randomization

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Age 35 to 50 years
• Male or Female
• 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 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"

Contacts and Locations

Locations

Australia, New South Wales

Woolcock Institute of Medical Research

Glebe, New South Wales, Australia, 2050

Sponsors and Collaborators

Elastagen Pty Ltd

Investigators

• Principal Investigator: Carlos China, MBBS; Woolcock Institute Medical Research

More Information

• Responsible Party: Elastagen Pty Ltd
• ClinicalTrials.gov Identifier: NCT01466413
• Other Study ID Numbers: ELAPR P1B
• First Posted: November 8, 2011
• Last Update Posted: October 15, 2012
• Last Verified: October 2012

Keywords provided by Elastagen Pty Ltd:

Intrinsic Aging of Skin