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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

April 30, 2010
February 9, 2011
April 2010
June 2012   (final data collection date for primary outcome measure)
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

Same as current
Complete list of historical versions of study NCT01115868 on ClinicalTrials.gov Archive Site
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Not Provided
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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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Scarring
  • 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 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
56
August 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01115868
RN1003-0110
No
Dr J Bush, Renovo
Renovo
Not Provided
Not Provided
Renovo
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP