Prevascar in African Continental Group Scarring
Recruitment status was Active, not recruiting
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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 |
- 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 |
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 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 May 16, 2013