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RN1006 has been developed as a stabilized formulation of avotermin which, when dosed once in pre-clinical studies in animals, has shown comparable scar improvement efficacy to the standard twice-dosed Juvista formulation. The aim of this trial is to investigate the efficacy of RN1006 compared to Juvista in a human volunteer model
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1a | Experimental | 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. |
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| 1b | Experimental | 250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. |
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| 1c | Experimental | 250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. |
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| 1d | Experimental | 500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. |
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| 2a | Experimental | 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Juvista (Avotermin) | Drug | 250 ng, twice, intradermal injection, standard formulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Global scar comparison scale | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event incidence including specific assessment of local tolerability at the treated wound site | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renovo CTU | Manchester | M13 9XX | United Kingdom |
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| 2b | Experimental | 500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. |
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| 2c | Experimental | 500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. |
|
| 2d | Experimental | 500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose (i.e. two doses in total). |
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| RN1006 (Avotermin) | Drug | 250 ng, intradermal injection, twice |
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| RN1006 (Avotermin) | Drug | 205 ng, Intradermal injection, once |
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| RN1006 (Avotermin) | Drug | 500ng, intradermal injection, once |
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| Juvista (Avotermin) | Drug | 250 ng, intradermal injection, twice |
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| Juvista (Avotermin) | Drug | 500 ng, intradermal injection, once |
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| Juvista (Avotermin) | Drug | 500 ng, intradermal injection, once |
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| RN1006 (Avotermin) | Drug | 500 ng, intradermal injection, twice |
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| Placebo | Drug | Placebo |
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| ID | Term |
|---|---|
| C509044 | TGFB3 protein, human |
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