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This is 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ELAPR001 | Active Comparator | Tropoelastin 0.1ml SC implant |
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| ELAPR002 | Active Comparator | Tropoelastin 0.1ml SC implant |
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| ELAPR003 | Active Comparator | Tropoelastin 0.1ml SC implant |
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| Saline | Placebo Comparator | Normal Saline 0.9% |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELAPR | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Persistence | To determine implant persistence by histopathology and clinical observation | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos China, MBBS | Woolcock Institute of Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woolcock Institute of Medical Research | Glebe | New South Wales | 2037 | Australia |
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| ELAPR | Device | Implant area of the medial aspect of the upper arm along the posterior line of the bicep is to be selected where there are no pigmentations or moles. Injections will be marked with a tattoo and placed at 2 cm intervals. The order is to be from proximal to distal control, ELAPR001, ELAPR002, ELAPR003 |
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