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
  Purpose

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 Intervention Phase
Scarring
Drug: Prevascar 5ng
Drug: Prevascar 25ng
Drug: Prevascar 100ng
Drug: Prevascar 250ng
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Renovo:

Primary Outcome Measures:
  • 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



Estimated Enrollment: 56
Study Start Date: April 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115868

Locations
United Kingdom
Renovo Clinical Trials Unit
Manchester, Greater Manchester, United Kingdom, M13 9XX
Sponsors and Collaborators
Renovo
  More Information

No publications provided

Responsible Party: Dr J Bush, Renovo
ClinicalTrials.gov Identifier: NCT01115868     History of Changes
Other Study ID Numbers: RN1003-0110
Study First Received: April 30, 2010
Last Updated: February 9, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014