Prevascar in African Continental Group Scarring

NCT ID: NCT01115868

Last Updated: 2011-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2012-08-31

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.

Conditions

Scarring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 2 - 2 doses of Prevascar and placebo

Group Type: EXPERIMENTAL

Prevascar 5ng

Intervention Type: DRUG

100uL of 5ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Prevascar 25ng

Intervention Type: DRUG

• 100uL of 25ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Prevascar 100ng

Intervention Type: DRUG

• 100uL of 100ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Prevascar 250ng

Intervention Type: DRUG

• 100uL of 250ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Group 1 - 2 doses of Prevascar and placebo

Group Type: EXPERIMENTAL

Prevascar 5ng

Intervention Type: DRUG

100uL of 5ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Prevascar 25ng

Intervention Type: DRUG

• 100uL of 25ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Prevascar 100ng

Intervention Type: DRUG

• 100uL of 100ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Prevascar 250ng

Intervention Type: DRUG

• 100uL of 250ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Group 3 - 2 doses of Prevascar and placebo

Group Type: EXPERIMENTAL

Prevascar 5ng

Intervention Type: DRUG

100uL of 5ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Prevascar 25ng

Intervention Type: DRUG

• 100uL of 25ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Prevascar 100ng

Intervention Type: DRUG

• 100uL of 100ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Prevascar 250ng

Intervention Type: DRUG

• 100uL of 250ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Group 4 - 2 doses of Prevascar and placebo

Group Type: EXPERIMENTAL

Prevascar 5ng

Intervention Type: DRUG

100uL of 5ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Prevascar 25ng

Intervention Type: DRUG

• 100uL of 25ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Prevascar 100ng

Intervention Type: DRUG

• 100uL of 100ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Prevascar 250ng

Intervention Type: DRUG

• 100uL of 250ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Interventions

Prevascar 5ng

100uL of 5ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Intervention Type: DRUG

Prevascar 25ng

• 100uL of 25ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Intervention Type: DRUG

Prevascar 100ng

• 100uL of 100ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Intervention Type: DRUG

Prevascar 250ng

• 100uL of 250ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Renovo

INDUSTRY

Sponsor Role: lead

Responsible Party

Renovo

Locations

Renovo Clinical Trials Unit

Manchester, Greater Manchester, United Kingdom

Countries

United Kingdom

Other Identifiers

RN1003-0110

Identifier Type: -

Identifier Source: org_study_id