NCT01466413

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Elastagen Pty Ltd · Industry
• Sex: All
• Age: 35 Years – 50 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Intrinsic Aging of Skin

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-11-08
• Last updated: 2012-10-15

Locations

1 site across 1 country: Australia