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There is considerable variation in scarring, within and between people, and between different ethnic groups. Individuals with more pigmented skin are more prone to severe scarring than those traditionally termed white. Prevascar is being developed by Renovo for use as a potential treatment for reducing scarring.
Renovo's histological analysis of wounds and scars in human non drug studies demonstrates an increase in wound and scar width in subjects of African Caribbean ancestry over a 12 month period.
It is hypothesised that IL-10 may be a potentially beneficial therapy for the reduction of scarring in Non Caucasians of African-Caribbean ancestry.
This Renovo clinical trial will be carried out primarily to establish the effects of four doses of Prevascar on 1cm incisional and excisional scars in subjects of African Continental Group ancestry, as compared to placebo, and to further investigate the safety and tolerance of intradermally injected Prevascar in wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 2 - 2 doses of Prevascar and placebo | Experimental |
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| Group 1 - 2 doses of Prevascar and placebo | Experimental |
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| Group 3 - 2 doses of Prevascar and placebo | Experimental |
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| Group 4 - 2 doses of Prevascar and placebo | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevascar 5ng | Drug | 100uL of 5ng/100uL Prevascar per linear centimetre wound margin injected intradermally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effects of Prevascar on resultant scars | To investigate the effects of Prevascar on wound/scar width To investigate the effects of Prevascar on wound/scar tissue histology To investigate the effects of Prevascar on scar appearance NB: This is an exploratory study and hence all objectives are exploratory | 13 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renovo Clinical Trials Unit | Manchester | Greater Manchester | M13 9XX | United Kingdom |
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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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| Prevascar 25ng | Drug | • 100uL of 25ng/100uL Prevascar per linear centimetre wound margin injected intradermally. |
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| Prevascar 100ng | Drug | • 100uL of 100ng/100uL Prevascar per linear centimetre wound margin injected intradermally. |
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| Prevascar 250ng | Drug | • 100uL of 250ng/100uL Prevascar per linear centimetre wound margin injected intradermally. |
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