MedTrace Logo

Safety Study of Three Formulations of the Dermal Implant ELAPR

NCT01467778 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2011-11-09

No results posted yet for this study

Summary

This is a Phase I study to assess the safety of three formulations of the dermal implant ELAPR.

Conditions

  • Skin Conditions

Interventions

DEVICE

ELAPR

ELAPR implant product is under development for mid to deep dermal implantation for the treatment of the symptoms of skin aging including the correction of moderate to sever facial wrinkles and folds, such as nasolabial folds and skin abnormalities such as scars.

DEVICE

ELAPR

Implant area of the medial aspect of the upper arm along the posterior line of the bicep is to be selected where there are no pigmentations or moles. Injections will be marked with a tattoo and placed at 2 cm intervals. The order is to be from proximal to distal control, ELAPR001, ELAPR002, ELAPR003

Sponsors & Collaborators

  • Elastagen Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Carlos China, MBBS · Woolcock Institute of Medical Research

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-03-31
Completion
2011-05-31

Countries

  • Australia

Study Locations

More Related Trials

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 NCT01467778 on ClinicalTrials.gov