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This study was undertaken to investigate the scar-improvement efficacy and safety of a single dose of avotermin (Juvista) injection into skin incisions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Avotermin 5ng/100μL/linear cm wound margin |
|
| 2 | Placebo Comparator | Placebo |
|
| 3 | Experimental | Avotermin 50ng/100μL/linear cm wound margin |
|
| 4 | Placebo Comparator | Placebo matched to avotermin 50ng/100μL/linear cm |
|
| 5 | Experimental | Avotermin 200ng/100μL/linear cm |
|
| 6 | Placebo Comparator | Placebo matched to avotermin 200ng/100μL/linear cm |
|
| 7 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avotermin | Drug | A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scar appearance | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: adverse events, local tolerability | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Bush, MBChB | Renovo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renovo Clinical Trials Unit | Manchester | M139XX | United Kingdom |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| C566254 | Arrhythmogenic Right Ventricular Dysplasia, Familial, 1 |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C509044 | TGFB3 protein, human |
| D053782 | Transforming Growth Factor beta3 |
| ID | Term |
|---|---|
| D016212 | Transforming Growth Factor beta |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| Experimental |
Avotermin 500ng/100μL/linear cm wound margin |
|
| 8 | Placebo Comparator | Placebo matched to avotermin 500ng/100μL/linear cm |
|
|
| Placebo | Drug | Matched to avotermin dosage strength |
|
|
| D000602 | Amino Acids, Peptides, and Proteins |
| D055411 | TGF-beta Superfamily Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |