Prevascar in African Continental Group Scarring

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2011 by Renovo.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Renovo

ClinicalTrials.gov Identifier:

NCT01115868

First received: April 30, 2010

Last updated: February 9, 2011

Last verified: February 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	April 30, 2010
Last Updated Date	February 9, 2011
Start Date ^ICMJE	April 2010
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 3, 2010)	To assess the effects of Prevascar on resultant scars [ Time Frame: 13 months ] [ Designated as safety issue: No ] 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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01115868 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prevascar in African Continental Group Scarring
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Scarring
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: Group 2 - 2 doses of Prevascar and placebo Interventions: Drug: Prevascar 5ng Drug: Prevascar 25ng Drug: Prevascar 100ng Drug: Prevascar 250ng Experimental: Group 1 - 2 doses of Prevascar and placebo Interventions: Drug: Prevascar 5ng Drug: Prevascar 25ng Drug: Prevascar 100ng Drug: Prevascar 250ng Experimental: Group 3 - 2 doses of Prevascar and placebo Interventions: Drug: Prevascar 5ng Drug: Prevascar 25ng Drug: Prevascar 100ng Drug: Prevascar 250ng Experimental: Group 4 - 2 doses of Prevascar and placebo Interventions: Drug: Prevascar 5ng Drug: Prevascar 25ng Drug: Prevascar 100ng Drug: Prevascar 250ng
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	56
Estimated Completion Date	August 2012
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01115868
Other Study ID Numbers ^ICMJE	RN1003-0110
Has Data Monitoring Committee	No
Responsible Party	Dr J Bush, Renovo
Study Sponsor ^ICMJE	Renovo
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Renovo
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top