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

NCT01466413 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2012-10-15

No results posted yet for this study

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.

Conditions

  • Intrinsic Aging of Skin

Interventions

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.

Sponsors & Collaborators

  • Elastagen Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Carlos China, MBBS · Woolcock Institute Medical Research

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01466413 on ClinicalTrials.gov