Prevascar in African Continental Group Scarring

Phase 1

• Conditions: Scarring
• Interventions: Drug: Prevascar 5ng; Drug: Prevascar 25ng; Drug: Prevascar 100ng; Drug: Prevascar 250ng

• Registration Number: NCT01115868
• Lead Sponsor: Renovo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-30
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-09
• Last Update Posted: 2011-02-10
• Primary Completion: 2012-06
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 - 2 doses of Prevascar and placebo	Prevascar 5ng	-
Group 2 - 2 doses of Prevascar and placebo	Prevascar 25ng	-
Group 2 - 2 doses of Prevascar and placebo	Prevascar 100ng	-
Group 2 - 2 doses of Prevascar and placebo	Prevascar 250ng	-
Group 1 - 2 doses of Prevascar and placebo	Prevascar 5ng	-
Group 1 - 2 doses of Prevascar and placebo	Prevascar 25ng	-
Group 1 - 2 doses of Prevascar and placebo	Prevascar 100ng	-
Group 1 - 2 doses of Prevascar and placebo	Prevascar 250ng	-
Group 3 - 2 doses of Prevascar and placebo	Prevascar 5ng	-
Group 3 - 2 doses of Prevascar and placebo	Prevascar 100ng	-
Group 3 - 2 doses of Prevascar and placebo	Prevascar 25ng	-
Group 3 - 2 doses of Prevascar and placebo	Prevascar 250ng	-
Group 4 - 2 doses of Prevascar and placebo	Prevascar 5ng	-
Group 4 - 2 doses of Prevascar and placebo	Prevascar 25ng	-
Group 4 - 2 doses of Prevascar and placebo	Prevascar 100ng	-
Group 4 - 2 doses of Prevascar and placebo	Prevascar 250ng	-

Primary Outcome Measures

Name	Time	Method
To assess the effects of Prevascar on resultant scars	13 months	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

Trial Locations

Locations (1)

Renovo Clinical Trials Unit; 🇬🇧 Manchester, Greater Manchester, United Kingdom