drugset / Trial / NCT01115868

Prevascar in African Continental Group Scarring

NCT01115868 ↗

Phase 1 Unknown 56 enrolled Renovo
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2010-04
Primary completion
2012-06
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Subject ILODECAKIN Protein / enzyme biologic 5 ng Other
Subject ILODECAKIN Protein / enzyme biologic 25 ng Other
Subject ILODECAKIN Protein / enzyme biologic 100 ng Other
Subject ILODECAKIN Protein / enzyme biologic 250 ng Other

Indications

No indication recorded.