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

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.

Study Overview

• Status: Unknown
• Conditions: Scarring
• Intervention / Treatment: Drug: Prevascar 5ng; Drug: Prevascar 25ng; Drug: Prevascar 100ng; Drug: Prevascar 250ng

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M13 9XX
      • Renovo Clinical Trials Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 2 - 2 doses of Prevascar and placebo	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.
Experimental: Group 1 - 2 doses of Prevascar and placebo	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.
Experimental: Group 3 - 2 doses of Prevascar and placebo	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.
Experimental: Group 4 - 2 doses of Prevascar and placebo	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the effects of Prevascar on resultant scars	To investigate the effects of Prevascar on wound/scar width To investigate the effects of Prevascar on wound/scar tissue histology To investigate the effects of Prevascar on scar appearance NB: This is an exploratory study and hence all objectives are exploratory	13 months

Collaborators and Investigators

• Sponsor: Renovo

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: April 30, 2010
• First Submitted That Met QC Criteria: May 3, 2010
• First Posted (Estimate): May 4, 2010

Study Record Updates

• Last Update Posted (Estimate): February 10, 2011
• Last Update Submitted That Met QC Criteria: February 9, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: RN1003-0110