A Phase I study to assess the safety 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.
Elastagen Pty Ltd
12 participants
Nov 22, 2010
Interventional
Conditions
Summary
Elastin is a major structural component of the skin which enables the skin to stretch and recoil. The loss or damage of elastin in the skin results in a range of skin abnormalities including, the symptoms of skin aging such as wrinkles, scars and the signs of sun damage. ELAPR is a dermal implant which is made from a synthetic form of human elastin and is being developed as a product which may be injected superficially into the skin using very fine needles to treat skin abnormalities associated with the loss of elastin. The synthetic human elastin which is the basis of the ELAPR dermal implant is a completely new product and the purpose of the current clinical trial is to evaluate the safety of the product in humans. The trial will involve the implantation of a small volume of the product in the skin of the upper arm of study participants. The implant will remain in the skin for a period of up to 29 days. The implant will then be removed by a needle biopsy to allow studies to be carried out on the tissue surrounding the implant to see how the body responded to the presence of the implant in the skin. The results of this study will provide a good understanding of how well the body tolerates this new synthetic human elastin material. If the synthetic elastin is well tolerated by the body then further studies will be undertaken to study its use in the treatment of skin abnormalities resulting from aging, scarring and sun damage.
Eligibility
Inclusion Criteria2
- Age
- Good general health status
Exclusion Criteria17
- 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
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Interventions
Three formulations of the dermal implant ELAPR are to be evaluated in the study. All three formulations are based on the protein tropoelastin which is the building block of elastin - a major structural component of the skin providing it with its ability to stretch and recoil. The three formulations differ in the presentation of the tropoelastin: formulation 1 is the tropoelastin alone; formulation 2 contains a combination of tropoelastin and hyaluronic acid; formulation 3 contains tropoelastin cross-linked with glutaraldehyde. Each of the 12 participants will receive a 0.1ml implant of each of the three formulations of ELAPR and one of a saline control (total four implants) in the medial aspect of the upper arm. All four implant sites will be subject to a single biopsy at three separate time points - four participants will have their implants biopsied at Day 8, four at Day 15 and four at Day 29.
Locations(1)
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ACTRN12610000871044