Safety Study of Three Formulations of the Dermal Implant ELAPR

November 7, 2011 updated by: Elastagen Pty Ltd

A Phase I Study to Assess the Safety of Three Formulations of the Dermal Implant ELAPR in Healthy Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Phase I study to assess the safety of three formulations of the dermal implant ELAPR in healthy subjects.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Glebe, New South Wales, Australia, 2037
        • Woolcock Institute of Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Good general health status

Exclusion Criteria:

  • Clinically significant abnormalities of haematology or biochemistry testing
  • Bleeding diathesis, anticoagulant drugs,thrombocytopenia or clinically significant prolonged APTT or PT
  • Chronic use of aspirin, other non-steroidal antiinflammatory drugs or other anti-platelet agents
  • History of keloid formation
  • Systemic corticosteroids within last 12 weeks
  • Diabetes or metabolic disorders
  • Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication
  • Pregnancy/lactation
  • A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ELAPR001
Tropoelastin 0.1ml SC implant
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.
Other Names:
  • Other Names:
  • Tropoelastin 0.1ml SC implant
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
Other Names:
  • Tropoelastin 0.1ml SC implant
Active Comparator: ELAPR002
Tropoelastin 0.1ml SC implant
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.
Other Names:
  • Other Names:
  • Tropoelastin 0.1ml SC implant
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
Other Names:
  • Tropoelastin 0.1ml SC implant
Active Comparator: ELAPR003
Tropoelastin 0.1ml SC implant
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.
Other Names:
  • Other Names:
  • Tropoelastin 0.1ml SC implant
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
Other Names:
  • Tropoelastin 0.1ml SC implant
Placebo Comparator: Saline
Normal Saline 0.9%
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.
Other Names:
  • Other Names:
  • Tropoelastin 0.1ml SC implant
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
Other Names:
  • Tropoelastin 0.1ml SC implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability measured by the amount of adverse events and serious adverse events
Time Frame: 6 weeks
To assess the safety and tolerability of a single course of intradermal injections of ELAPR when administered to healthy subjects by reported adverse events and serious adverse events
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistence
Time Frame: 6 weeks
To determine implant persistence by histopathology and clinical observation
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elastagen Pty Ltd

Investigators

  • Principal Investigator: Carlos China, MBBS, Woolcock Institute of Medical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

March 22, 2011

First Submitted That Met QC Criteria

November 7, 2011

First Posted (Estimate)

November 9, 2011

Study Record Updates

Last Update Posted (Estimate)

November 9, 2011

Last Update Submitted That Met QC Criteria

November 7, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELAPR-P1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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