Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upper Arm Dermis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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|
- Assess the persistence and tissue compatibility with histopathology. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]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.
- Assess the acute and chronic safety of ELAPR. [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]Biopsy at day 85 or day 169 depending on randomization
|Study Start Date:||September 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466413
|Australia, New South Wales|
|Woolcock Institute of Medical Research|
|Glebe, New South Wales, Australia, 2050|
|Principal Investigator:||Carlos China, MBBS||Woolcock Institute Medical Research|