A Phase I study to assess the safety of three formulations of the dermal implant ELAPR
Phase 1
Completed
- Conditions
- Healthy subjects are to be used in the study to assess the safety of the dermal implant.The dermal implant ELAPR is being developed to treat the symptoms of skin aging or damage including wrinkles, scarring and photoaging.Skin - Other skin conditions
- Registration Number
- ACTRN12610000871044
- Lead Sponsor
- Elastagen Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Age
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
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of a single course of intradermal injections of ELAPR when administered to healthy subjects. This will be assessed by clinical observation of the implant sites throughout the duration of the study; haematology and blood biochemistry analysis; and, histopathology and immunohistochemistry of a tissue biopsy sample from each implant site to evaluate implant persistance and identify any cellular responses to the implant material.[- Clinical evaluation of the implant sites will occur for 60 minutes after implantation and on Days 4, 8, 15, 29 and 43.<br>- Blood haematology and biochemical analysis will occur during screening and at Day 1, 4 and 29.<br>- Biopsies for histopathology will be taken on Day 8, 15 and 29 (four participants each).]
- Secondary Outcome Measures
Name Time Method To determine implant persistence by histopathology and clinical observation[- Clinical evaluation of the implant sites will occur for 60 minutes after implantation and on Days 4, 8, 15, 29 and 43.<br>- Biopsies for histopathology will be taken on Day 8, 15 and 29 (four participants each).]