Prevascar in African Continental Group Scarring

• Sponsor: Renovo (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01115868
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 4
• Duration (Months): 28
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Scarring	Drug: Prevascar 5ng; Drug: Prevascar 25ng; Drug: Prevascar 100ng; Drug: Prevascar 250ng	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Apr 1, 2010
• Anticipated Primary Completion Date: Jun 1, 2012
• Anticipated Study Completion Date: Aug 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. To assess the effects of Prevascar on resultant scars [13 months]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renovo Clinical Trials Unit	Manchester	Greater Manchester	United Kingdom	M13 9XX

Sponsors and Collaborators

• Renovo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01115868
• Other Study ID Numbers: RN1003-0110
• First Posted: May 4, 2010
• Last Update Posted: Feb 10, 2011
• Last Verified: Feb 1, 2011

• Additional relevant MeSH terms: Cicatrix

Study Results

No Results Posted as of Feb 10, 2011