Scarring Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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