NCT01115868

Prevascar in African Continental Group Scarring

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Renovo · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Scarring

Interventions

Type	Name	Description
DRUG	Prevascar 5ng	100uL of 5ng/100uL Prevascar per linear centimetre wound margin injected intradermally.
DRUG	Prevascar 25ng	• 100uL of 25ng/100uL Prevascar per linear centimetre wound margin injected intradermally.
DRUG	Prevascar 100ng	• 100uL of 100ng/100uL Prevascar per linear centimetre wound margin injected intradermally.
DRUG	Prevascar 250ng	• 100uL of 250ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-06-01
• Completion: 2012-08-01
• First posted: 2010-05-04
• Last updated: 2011-02-10

Locations

1 site across 1 country: United Kingdom