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This will be a multi-centre, double-blind, within-subject, placebo controlled randomised trial in female subjects. All subjects will undergo bilateral breast augmentation surgery. Immediately following surgery, each subject will receive 100µl containing 50ng or 200ng of RN1001 per linear centimetre intradermally into both margins of one breast wound, and 100µl of placebo solution per linear centimetre intradermally into both margins of their other breast wound. The allocation of treatment to wound (left or right) will be randomised and double blind.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avotermin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator scar assessment | ||
| Patient scar assessment | ||
| Independent scar assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Local tolerance | ||
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Whitby | BUPA Hospital Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fitzwilliam Clinic | Belfast | BT9 6AF | United Kingdom | |||
| The Grosvenor Nuffield Hospital |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C509044 | TGFB3 protein, human |
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| Chester |
| CH4 7QP |
| United Kingdom |
| Classic Hull & East Riding | Hull | HU10 7AZ | United Kingdom |
| Hull Nuffield Hospital | Hull | HU16 5FQ | United Kingdom |
| Renovo CTU | Manchester | M13 9XX | United Kingdom |
| BUPA Hospital | Manchester | M16 8AJ | United Kingdom |
| BUPA North Cheshire Hospital | Warrington | WA4 4LU | United Kingdom |