Safety Study of Three Formulations of the Dermal Implant ELAPR
A Phase I Study to Assess the Safety of Three Formulations of the Dermal Implant ELAPR in Healthy Subjects
1 other identifier
interventional
14
1 country
1
Brief Summary
This is a Phase I study to assess the safety of three formulations of the dermal implant ELAPR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 22, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Posted
Study publicly available on registry
November 9, 2011
CompletedNovember 9, 2011
November 1, 2011
3 months
March 22, 2011
November 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability measured by the amount of adverse events and serious adverse events
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 Outcomes (1)
Persistence
6 weeks
Study Arms (4)
ELAPR001
ACTIVE COMPARATORTropoelastin 0.1ml SC implant
ELAPR002
ACTIVE COMPARATORTropoelastin 0.1ml SC implant
ELAPR003
ACTIVE COMPARATORTropoelastin 0.1ml SC implant
Saline
PLACEBO COMPARATORNormal Saline 0.9%
Interventions
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.
Eligibility Criteria
You may qualify if:
- Good general health status
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Woolcock Institute of Medical Research
Glebe, New South Wales, 2037, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos China, MBBS
Woolcock Institute of Medical Research
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2011
First Posted
November 9, 2011
Study Start
December 1, 2010
Primary Completion
March 1, 2011
Study Completion
May 1, 2011
Last Updated
November 9, 2011
Record last verified: 2011-11