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Completed

NCT Number: NCT01467778

Safety Study of Three Formulations of the Dermal Implant ELAPR

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

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Key information

Conditions

Skin Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Woolcock Institute of Medical Research

Glebe, New South Wales, 2037, Australia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ELAPR

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Persistence

    Time frame: 6 weeks

    To determine implant persistence by histopathology and clinical observation

Sponsors and collaborators

Lead sponsor

Elastagen Pty Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 9, 2011
Registry last updated
Nov 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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