Prevascar in African Continental Group Scarring

Study Overview
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Brief Summary
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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.

Official Title
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An Exploratory, Single Centre, Randomized, Placebo Controlled, Assessor Blind Clinical Trial to Assess the Effects of Intradermal Administrations of Prevascar on Scarring in Human Subjects of African Continental Ancestral Origin

Conditions
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Scarring

Intervention / Treatment
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* Drug: Prevascar 5ng
* Drug: Prevascar 25ng
* Drug: Prevascar 100ng
* Drug: Prevascar 250ng


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Afro-Caribbean male and female subjects between 18 and 85 years of age. Exclusion Criteria: Subjects who on direct questioning or examination have history or evidence of keloid scarring. Subjects who have evidence of any past or present clinically significant medical condition that would impair wound healing or trial assessments Subjects with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial. Subjects who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit. Female subjects who are, or who become pregnant up to and including Day 0 and/ or who are lactating. In the opinion of the Investigator, a subject who is not likely to complete the trial for whatever reason.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 2 - 2 doses of Prevascar and placebo<br> | Drug: Prevascar 5ng<br>* 100uL of 5ng/100uL Prevascar per linear centimetre wound margin injected intradermally.<br>Drug: Prevascar 25ng<br>* • 100uL of 25ng/100uL Prevascar per linear centimetre wound margin injected intradermally.<br>Drug: Prevascar 100ng<br>* • 100uL of 100ng/100uL Prevascar per linear centimetre wound margin injected intradermally.<br>Drug: Prevascar 250ng<br>* • 100uL of 250ng/100uL Prevascar per linear centimetre wound margin injected intradermally.<br>|
| Experimental: Group 1 - 2 doses of Prevascar and placebo<br> | Drug: Prevascar 5ng<br>* 100uL of 5ng/100uL Prevascar per linear centimetre wound margin injected intradermally.<br>Drug: Prevascar 25ng<br>* • 100uL of 25ng/100uL Prevascar per linear centimetre wound margin injected intradermally.<br>Drug: Prevascar 100ng<br>* • 100uL of 100ng/100uL Prevascar per linear centimetre wound margin injected intradermally.<br>Drug: Prevascar 250ng<br>* • 100uL of 250ng/100uL Prevascar per linear centimetre wound margin injected intradermally.<br>|
| Experimental: Group 3 - 2 doses of Prevascar and placebo<br> | Drug: Prevascar 5ng<br>* 100uL of 5ng/100uL Prevascar per linear centimetre wound margin injected intradermally.<br>Drug: Prevascar 25ng<br>* • 100uL of 25ng/100uL Prevascar per linear centimetre wound margin injected intradermally.<br>Drug: Prevascar 100ng<br>* • 100uL of 100ng/100uL Prevascar per linear centimetre wound margin injected intradermally.<br>Drug: Prevascar 250ng<br>* • 100uL of 250ng/100uL Prevascar per linear centimetre wound margin injected intradermally.<br>|
| Experimental: Group 4 - 2 doses of Prevascar and placebo<br> | Drug: Prevascar 5ng<br>* 100uL of 5ng/100uL Prevascar per linear centimetre wound margin injected intradermally.<br>Drug: Prevascar 25ng<br>* • 100uL of 25ng/100uL Prevascar per linear centimetre wound margin injected intradermally.<br>Drug: Prevascar 100ng<br>* • 100uL of 100ng/100uL Prevascar per linear centimetre wound margin injected intradermally.<br>Drug: Prevascar 250ng<br>* • 100uL of 250ng/100uL Prevascar per linear centimetre wound margin injected intradermally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |