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This trial will assess the safety and efficacy of 500ng Juvista per linear cm of wound margin administered by intradermal injection following the excision of keloid scars on the ear lobe. Ear lobe keloids commonly occur after ear piercing and can be particularly distressing for patients as they are very difficult to conceal and are usually bilateral. As the recurrence rate and growth rate of keloids can vary significantly between individuals, trial subjects will have bilateral ear lobe keloids and will act as their own control. One ear lobe will be treated with Juvista following keloid excision and one with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | 500ng dose |
|
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avotermin | Drug | 10 patients undergoing surgical revision of bilateral keloids will be dosed with 500ng Juvista/100µL per cm of wound margin to one ear lobe and placebo to the other and followed up for three months after dosing to assess the local and systemic tolerability. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse events | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Keliod recurrence | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| V V Young, MD | Body Aesthetic Plastic Surgery and Skincare Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Body Aesthetic Plastic Surgery and Skincare Center | St Louis | Missouri | 63141 | United States |
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| ID | Term |
|---|---|
| D007627 | Keloid |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
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| ID | Term |
|---|---|
| C509044 | TGFB3 protein, human |
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| placebo | Drug | placebo |
|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |