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Prevascar in African Continental Group Scarring

NCT01115868 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2011-02-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Renovo

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-06-30
Completion
2012-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01115868 on ClinicalTrials.gov