Status:
COMPLETED
Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upper Arm Dermis
Lead Sponsor:
Elastagen Pty Ltd
Conditions:
Intrinsic Aging of Skin
Eligibility:
All Genders
35-50 years
Phase:
PHASE1
Brief Summary
This is an early phase study comparing two fixed dose of the study compound ELAPR and a Restylane® Vital Light (control), by multiple intradermal injections to a 3cm x 3cm area of the upper arm dermis...
Detailed Description
Each subject will also receive Restylane® Vital Light (control) to the opposite arm following the same treatment regimen and using the same technique. A 4mm skin biopsy will be taken from each of the ...
Eligibility Criteria
Inclusion
- Age 35 to 50 years
- Male or Female
- Good general health status
- Able to give informed consent
Exclusion
- 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 anti-inflammatory drugs or other anti-platelet agents
- History of keloid formation
- Systemic corticosteroids within last 12 weeks
- Diabetes or other metabolic disorders that may interfere with the subject's response to treatment in the opinion of the investigator
- Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication
- Pregnancy/lactation
- Previously received Tropoelastin
- A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine
- Sensitivity to Restylane® Vital light or Restylane products
- Use of any other investigational product on the intended implant site in the previous 12 months.
- Sensitivity to topical local anaesthetic cream (EMLA®) or have the following conditions where EMLA is contraindicated: dermatitis, Methaemoglobinaemia, Glucose-6-phosphate dehydrogenase deficiency or "Mollusca Contagiosa"
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01466413
Start Date
September 1 2011
End Date
April 1 2012
Last Update
October 15 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Woolcock Institute of Medical Research
Glebe, New South Wales, Australia, 2050