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

Intrinsic Aging of Skin Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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

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

Related Conditions & MeSH terms

• Intrinsic Aging of Skin

• NCT number: NCT01466413
• Study type: Interventional
• Source: Elastagen Pty Ltd
• Status: Completed
• Phase: Phase 1
• Start date: September 2011
• Completion date: April 2012