NevusPhase 2NCT00656227
A Trial to Investigate Scar Improvement Efficacy of RN1001 (Avotermin) After Head and Neck Naevi Excision
A Phase 2 study testing Avotermin in people with Nevus and Cicatrix, run by Renovo at 1 site in United Kingdom.
Trial summary
This trial will investigate whether four doses of RN1001 (20ng, 50ng, 100ng and 200ng) are efficacious in preventing or reducing the resultant scar, as compared to placebo, when applied intradermally to wound margins following excision of benign naevi situated on the head and neck. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Avotermin
- How many people
- 239 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2004to Jul 2012
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Weight between 50 and 150kg and a body mass index within the permitted range for their height, using Quetelet's index-weight (kg)/height² (m). The permitted index is between 15-55.
- Subjects with one or more benign head and neck naevi which when measured are at least 3cm apart.
- Subjects who are aged 18-85 years.
Who cannot join
- Subjects who on examination have a naevus or naevi, which appear clinically suspicious of malignancy and therefore require specialist referral and treatment.
- Subjects who on direct questioning and physical examination have a history or evidence of hypertrophic or keloid scarring or tattoo(s) or previous scar(s) in the area to be excised.
- Subjects with a personal history of a bleeding disorder.
- Subjects with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of acute wounds or involves the areas to be examined in this trial.
- Subjects with any clinically significant medical condition that would impair wound healing including renal, hepatic, haematological, neurological or immune disease.
- Subjects with a history of clinically significant drug hypersensitivity to lignocaine or allergy to surgical dressings to be used in this trial.
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- Subjects with any clinically significant abnormality following review of pre trial laboratory data and physical examination.
- Subjects who are taking, or have taken, any investigational drugs within the last 30 days, long term oral, topical or inhaled corticosteroid therapy and anti coagulant or anti platelet medication.
- Certain drugs are not excluded in this trial. These include OTC analgesics including paracetamol and codeine, vitamin and mineral supplements and OTC cold remedies containing paracetamol as the active ingredient.
- Subjects who are pregnant or who become pregnant up to and including Day 0. Subjects must use suitable forms of contraception during at least the first two months of the trial.
- Subjects who have previously had a positive result to the test for HIV antibodies, or who admit to belonging to a high-risk group.
- 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.
About this study
Official title: A Double Blind, Placebo Controlled Randomised Trial to Investigate the Scar Improvement Efficacy of a Single Intradermal Application of RN1001 (Avotermin) in Subjects Undergoing Excision of Benign Head and Neck Naevi.
This trial will investigate whether four doses of RN1001 (20ng, 50ng, 100ng and 200ng) are efficacious in preventing or reducing the resultant scar, as compared to placebo, when applied intradermally to wound margins following excision of benign naevi situated on the head and neck.
Read the detailed description
Male and female subjects (aged between 18-85 years) with one or more benign head \& neck naevi will be invited to participate in the study.
Each patient will be randomised to a particular dose group, depending on the number of naevi suitable for excision. For example, patients with one excised naevi will receive either a dose of one of the concentrations of RN1001, or placebo. A patient with 2 excised naevi will receive an active dose, and placebo. Patients with 3 excised naevi will receive 2 active doses, plus placebo, and patient with four excised naevi will receive 3 active doses plus placebo.
Naevi will be excised using punch biopsy, and then closed with standard sutures. Following wound closure, the study drug (active RN1001 or placebo) will be administered via intradermal injection at a rate of 100ul per linear cm of wound margin.
Digital and film photography will be taken pre-dose and post dose (Day 0, day 14, day 28, Month 2, 3, 6 \& 12, and thereafter at M24, M36, M48 \& M60). Additionally, scar assessments (completed by Investigator, Research Nurse \& Medical photographer) will be completed at follow up visits from Day 20 onwards. Silicone moulds of the scars will be taken at M6, M12 and then annually to M60.
Patients will be requested to complete a questionnaire to rate their scar expectations/assessment on a total of 5 occasions (screening, Day 0, Month 3, Month 6 \& Month 12)
- Being tested
- Avotermin
- Medical subject headings
- Nevus, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvoterminDrug
Comparison of different dose levels (20ng, 50ng, 100ng or 200ng/100 ul) versus placebo
What is being measured
The primary outcome is the main question the study is designed to answer.
Month 12 VAs - difference between active and placebo
Measured: 12 month
Secondary outcomes (1)
VAS from the independent external panel
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startApr 2004
- Primary completionJul 2007
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NevusStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jim Bush, MB ChB, Principal investigator, Renovo Clinical Trials Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656227
- Sponsor's protocol ID
- RN1001-319-1008
- Status last verified
- Apr 2008
- First submitted
- 7 Apr 2008
- Last updated
- 11 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled Randomised Trial to Investigate the Scar Improvement Efficacy of a Single Intradermal Application of RN1001 (Avotermin) in Subjects Undergoing Excision of Benign Head and Neck Naevi.
- ClinicalTrials.gov ID
- NCT00656227
- Acronym / sponsor ID
- RN1001-319-1008
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 239 participants (actual)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2012 (estimated)
- First posted
- 11 Apr 2008 (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.
This trial will investigate whether four doses of RN1001 (20ng, 50ng, 100ng and 200ng) are efficacious in preventing or reducing the resultant scar, as compared to placebo, when applied intradermally to wound margins following excision of benign naevi situated on the head and neck.
Detailed description
Male and female subjects (aged between 18-85 years) with one or more benign head \& neck naevi will be invited to participate in the study.
Each patient will be randomised to a particular dose group, depending on the number of naevi suitable for excision. For example, patients with one excised naevi will receive either a dose of one of the concentrations of RN1001, or placebo. A patient with 2 excised naevi will receive an active dose, and placebo. Patients with 3 excised naevi will receive 2 active doses, plus placebo, and patient with four excised naevi will receive 3 active doses plus placebo.
Naevi will be excised using punch biopsy, and then closed with standard sutures. Following wound closure, the study drug (active RN1001 or placebo) will be administered via intradermal injection at a rate of 100ul per linear cm of wound margin.
Digital and film photography will be taken pre-dose and post dose (Day 0, day 14, day 28, Month 2, 3, 6 \& 12, and thereafter at M24, M36, M48 \& M60). Additionally, scar assessments (completed by Investigator, Research Nurse \& Medical photographer) will be completed at follow up visits from Day 20 onwards. Silicone moulds of the scars will be taken at M6, M12 and then annually to M60.
Patients will be requested to complete a questionnaire to rate their scar expectations/assessment on a total of 5 occasions (screening, Day 0, Month 3, Month 6 \& Month 12)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Weight between 50 and 150kg and a body mass index within the permitted range for their height, using Quetelet's index-weight (kg)/height² (m). The permitted index is between 15-55.
- Subjects with one or more benign head and neck naevi which when measured are at least 3cm apart.
- Subjects who are aged 18-85 years.
Key exclusion criteria (12 listed)
- Subjects who on examination have a naevus or naevi, which appear clinically suspicious of malignancy and therefore require specialist referral and treatment.
- Subjects who on direct questioning and physical examination have a history or evidence of hypertrophic or keloid scarring or tattoo(s) or previous scar(s) in the area to be excised.
- Subjects with a personal history of a bleeding disorder.
- Subjects with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of acute wounds or involves the areas to be examined in this trial.
- Subjects with any clinically significant medical condition that would impair wound healing including renal, hepatic, haematological, neurological or immune disease.
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 |
|---|---|---|
| AvoterminComparison of different dose levels (20ng, 50ng, 100ng or 200ng/100 ul) versus placebo | Drug | – |
Primary outcome
Month 12 VAs - difference between active and placebo
Time frame: 12 month
1 secondary outcome
VAS from the independent external panel
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2008.
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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.
Jim Bush, MB ChB principal investigator
Renovo Clinical Trials Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avotermin in people with Nevus and Cicatrix, 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 3 inclusion and 12 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 11 Apr 2008. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Month 12 VAs - difference between active and placebo (time frame: 12 month). 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 11 Apr 2008.