Prevascar in African Continental Group Scarring

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01115868
• Other study ID #: RN1003-0110
• Status: Active, not recruiting
• Phase: Phase 1
• First received: April 30, 2010
• Last updated: February 9, 2011
• Start date: April 2010
• Est. completion date: August 2012

Study information

• Verified date: February 2011
• Source: Renovo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix
• Scarring

Intervention

Drug:
• Prevascar 5ng
100uL of 5ng/100uL Prevascar per linear centimetre wound margin injected intradermally.
• Prevascar 25ng
• 100uL of 25ng/100uL Prevascar per linear centimetre wound margin injected intradermally.
• Prevascar 100ng
• 100uL of 100ng/100uL Prevascar per linear centimetre wound margin injected intradermally.
• Prevascar 250ng
• 100uL of 250ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Locations

Country	Name	City	State
United Kingdom	Renovo Clinical Trials Unit	Manchester	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Renovo

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No