ScarringPhase 1NCT01115868
Prevascar in African Continental Group Scarring
A Phase 1 study testing Prevascar 5ng, Prevascar 25ng and Prevascar 100ng in people with Scarring, run by Renovo at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Scarring
- What is being tested?
- Prevascar 5ng, Prevascar 25ng and Prevascar 100ng
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2010to Aug 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Afro-Caribbean male and female subjects between 18 and 85 years of age.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Renovo Clinical Trials Unit
Manchester, Greater Manchester, M13 9XX
About this study
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
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.
Read more
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.
- Conditions
- Scarring
- Being tested
- Prevascar 5ng, Prevascar 25ng, Prevascar 100ng, Prevascar 250ng
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevascar 5ngDrug
100uL of 5ng/100uL Prevascar per linear centimetre wound margin injected intradermally.
Prevascar 25ngDrug
- 100uL of 25ng/100uL Prevascar per linear centimetre wound margin injected intradermally.
Prevascar 100ngDrug
- 100uL of 100ng/100uL Prevascar per linear centimetre wound margin injected intradermally.
Prevascar 250ngDrug
- 100uL of 250ng/100uL Prevascar per linear centimetre wound margin injected intradermally.
| Study group | Role | What they receive |
|---|---|---|
| Group 2 - 2 doses of Prevascar and placebo | Experimental | Not described Receives: Drug: Prevascar 5ng; Drug: Prevascar 25ng; Drug: Prevascar 100ng; Drug: Prevascar 250ng |
| Group 1 - 2 doses of Prevascar and placebo | Experimental | Not described Receives: Drug: Prevascar 5ng; Drug: Prevascar 25ng; Drug: Prevascar 100ng; Drug: Prevascar 250ng |
| Group 3 - 2 doses of Prevascar and placebo | Experimental | Not described Receives: Drug: Prevascar 5ng; Drug: Prevascar 25ng; Drug: Prevascar 100ng; Drug: Prevascar 250ng |
| Group 4 - 2 doses of Prevascar and placebo | Experimental | Not described Receives: Drug: Prevascar 5ng; Drug: Prevascar 25ng; Drug: Prevascar 100ng; Drug: Prevascar 250ng |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effects of Prevascar on resultant scars
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
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115868
- Sponsor's protocol ID
- RN1003-0110
- Status last verified
- Feb 2011
- First submitted
- 30 Apr 2010
- Last updated
- 10 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01115868
- Acronym / sponsor ID
- RN1003-0110
- Conditions
- Scarring
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 2 - 2 doses of Prevascar and placebo | Experimental | Drug: Prevascar 5ng, Drug: Prevascar 25ng, Drug: Prevascar 100ng, Drug: Prevascar 250ng |
| Group 1 - 2 doses of Prevascar and placebo | Experimental | Drug: Prevascar 5ng, Drug: Prevascar 25ng, Drug: Prevascar 100ng, Drug: Prevascar 250ng |
| Group 3 - 2 doses of Prevascar and placebo | Experimental | Drug: Prevascar 5ng, Drug: Prevascar 25ng, Drug: Prevascar 100ng, Drug: Prevascar 250ng |
| Group 4 - 2 doses of Prevascar and placebo | Experimental | Drug: Prevascar 5ng, Drug: Prevascar 25ng, Drug: Prevascar 100ng, Drug: Prevascar 250ng |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Afro-Caribbean male and female subjects between 18 and 85 years of age.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevascar 5ng100uL of 5ng/100uL Prevascar per linear centimetre wound margin injected intradermally. | Drug | Group 1 - 2 doses of Prevascar and placebo, Group 2 - 2 doses of Prevascar and placebo, Group 3 - 2 doses of Prevascar and placebo, Group 4 - 2 doses of Prevascar and placebo |
| Prevascar 25ng• 100uL of 25ng/100uL Prevascar per linear centimetre wound margin injected intradermally. | Drug | Group 1 - 2 doses of Prevascar and placebo, Group 2 - 2 doses of Prevascar and placebo, Group 3 - 2 doses of Prevascar and placebo, Group 4 - 2 doses of Prevascar and placebo |
| Prevascar 100ng• 100uL of 100ng/100uL Prevascar per linear centimetre wound margin injected intradermally. | Drug | Group 1 - 2 doses of Prevascar and placebo, Group 2 - 2 doses of Prevascar and placebo, Group 3 - 2 doses of Prevascar and placebo, Group 4 - 2 doses of Prevascar and placebo |
| Prevascar 250ng• 100uL of 250ng/100uL Prevascar per linear centimetre wound margin injected intradermally. | Drug | Group 1 - 2 doses of Prevascar and placebo, Group 2 - 2 doses of Prevascar and placebo, Group 3 - 2 doses of Prevascar and placebo, Group 4 - 2 doses of Prevascar and placebo |
Primary outcome
To assess the effects of Prevascar on resultant scars
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prevascar 5ng, Prevascar 25ng and Prevascar 100ng in people with Scarring, run by Renovo at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effects of Prevascar on resultant scars (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2011.