Safety Study of Three Formulations of the Dermal Implant ELAPR

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elastagen Pty Ltd
ClinicalTrials.gov Identifier:
NCT01467778
First received: March 22, 2011
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Skin Conditions
Device: ELAPR
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase I Study to Assess the Safety of Three Formulations of the Dermal Implant ELAPR in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Elastagen Pty Ltd:

Primary Outcome Measures:
  • Safety and tolerability measured by the amount of adverse events and serious adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Persistence [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    To determine implant persistence by histopathology and clinical observation


Enrollment: 14
Study Start Date: December 2010
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Tropoelastin 0.1ml SC implant

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467778

Locations
Australia, New South Wales
Woolcock Institute of Medical Research
Glebe, New South Wales, Australia, 2037
Sponsors and Collaborators
Elastagen Pty Ltd
Investigators
Principal Investigator: Carlos China, MBBS Woolcock Institute of Medical Research
  More Information

No publications provided

Responsible Party: Elastagen Pty Ltd
ClinicalTrials.gov Identifier: NCT01467778     History of Changes
Other Study ID Numbers: ELAPR-P1
Study First Received: March 22, 2011
Last Updated: November 7, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Elastagen Pty Ltd:
skin

Additional relevant MeSH terms:
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014