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
Sponsor study identifier
interventional
16
1 country
1
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2012
Actual (reported)Study Completion
April 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
September 18, 2011
Actual (reported)November 8, 2011
Actual (reported)April 2012
Actual (reported)April 2012
Actual (reported)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
Assess the acute and chronic safety of ELAPR.
26 weeks
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Woolcock Institute of Medical Research
Glebe, New South Wales, 2050, Australia
Carlos China, MBBS
Woolcock Institute Medical Research
16 participants (actual enrollment reported by the registry).
First Submitted
September 18, 2011
First Posted
November 8, 2011
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
April 2012
Actual (reported)Study Completion
April 2012
Actual (reported)Last Updated
October 15, 2012
Record last verified: 2012-10
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Source: ClinicalTrials.gov.
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