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This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIPO-102 | Experimental | Intraorbital Injection |
|
| Placebo | Placebo Comparator | Intraorbital Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIPO-102 | Drug | intraorbital injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: physical examinations, laboratory tests, VISA activity score, AE assessments | 8 weeks treatment and 1 week follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction | 8 weeks treatment and 1 week follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adelaide | Australia | |||||
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| Drug |
intraorbital injection |
|
| Brisbane |
| Australia |
| Melbourne | Australia |
| Sydney | Australia |
| Auckland | New Zealand |