Safety Study of Three Formulations of the Dermal Implant ELAPR

Phase 1

Completed

• Conditions: Skin Conditions
• Interventions: Device: ELAPR

• Registration Number: NCT01467778
• Lead Sponsor: Elastagen Pty Ltd

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-03
• Study First Submitted: 2011-03-22
• Study Completion: 2011-05
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-07
• Last Update Submitted: 2011-11-07
• Study First Posted: 2011-11-09
• Last Update Posted: 2011-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ELAPR002	ELAPR	Tropoelastin 0.1ml SC implant
ELAPR001	ELAPR	Tropoelastin 0.1ml SC implant
ELAPR003	ELAPR	Tropoelastin 0.1ml SC implant
Saline	ELAPR	Normal Saline 0.9%

Primary Outcome Measures

Name	Time	Method
Safety and tolerability measured by the amount of adverse events and serious adverse events	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 Outcome Measures

Name	Time	Method
Persistence	6 weeks	To determine implant persistence by histopathology and clinical observation

Trial Locations

Locations (1)

Woolcock Institute of Medical Research; 🇦🇺 Glebe, New South Wales, Australia