CicatrixPhase 2NCT00432211
Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery.
A Phase 2 study testing Avotermin in people with Cicatrix, run by Renovo at 1 site in United Kingdom.
Trial summary
This study is being undertaken to investigate the efficacy and safety of Juvista (given as an intradermal injection of 200ng/100µl per linear centimetre of wound margin) in the prevention or improvement of scar appearance when administered intradermally to approximated wound margins following surgical scar revision. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cicatrix
- What is being tested?
- Avotermin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2006to Sep 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
- Subjects aged 18-85 years who have provided written informed consent.
- A body mass index between 15 and 35 kg/m2 .
- Subjects with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol.
- Female subjects of child bearing potential who are using method(s) of contraception acceptable to the Investigator and agree to do so from at least the screening visit until one month after administration of the final study dose.
- Subjects with linear scars that, in the opinion of the Investigator, are suitable for revision by excision and direct closure. The area of scar to be revised must be at least 5cm in length and have at least two comparable areas.
- Subjects, who, in the opinion of the Investigator have stabilised, mature scars.
Who cannot join
- Subjects who on direct questioning and physical examination have history or evidence of keloid scarring.
- Subjects with scars for revision that cross a joint or are in close proximity to an anatomical structure, which could lead to distortion of the resultant scar.
- Subjects with additional scars less than 3cm away from the area to be revised.
- Subjects with a history of a bleeding disorder.
- Subjects with diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerability or efficacy.
- Subjects who have had surgery in the area to be excised within one year of Day 0.
Show all 15Show fewer
- Subjects with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
- Subjects who on direct questioning and / or physical examination, have evidence of any past or present clinically significant medical condition that would impair wound healing.
- 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 including Juvista within 3 months prior to the screening visit.
- Subjects who are taking regular, continuous, oral corticosteroid therapy.
- Subjects who, in the opinion of the Investigator, have significant ongoing psychiatric disorders, which may interfere with the trial assessments / visits.
- Subjects undergoing investigations or changes in management for an existing medical condition.
- Subjects who are or who become pregnant up to and including Day 0 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.
About this study
Official title: A Double Blind, Placebo Controlled, Randomised Trial to Investigate the Efficacy of Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery.
This study is being undertaken to investigate the efficacy and safety of Juvista (given as an intradermal injection of 200ng/100µl per linear centimetre of wound margin) in the prevention or improvement of scar appearance when administered intradermally to approximated wound margins following surgical scar revision.
In addition, this study will compare the scar revision techniques of complete excision (excision of the entire scar during one surgical procedure) and staged excision (excision of the outmost segments and central core separately).
- Conditions
- Cicatrix
- Being tested
- Avotermin
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvoterminDrug
Complete Excision:- On Day 0,Following wound closure the two outer segments of the wound will receive either Juvista or placebo.100µl of vehicle containing 200ng of Juvista will be injected per linear centimetre into both margins of one segment of the wound,and 100µl of vehicle alone (placebo) will be injected per linear centimetre into the other segment of the wound. There will be a central area (at least 3cm) of untreated wound between the two segments.The treatments will be re-administered to each wound segment (A and B) 24 hours after the first administration.
Staged Excision On Day 0, the two end segments of the scar will be excised.Following wound closure each subject will receive 100µl of vehicle containing 200ng of Juvista per linear centimetre intradermally into one wound, and 100µl of vehicle alone (placebo) per linear centimetre into the other wound.The trial treatments will be re-administered to each wound 24 hours after the first administration.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Complete Scar Excision Receives: Drug: Avotermin |
| 2 | Placebo comparator | Staged Excision of scar Receives: Drug: Avotermin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator scar assessment
Measured: up to 7 month visit
Patient scar assessment
Measured: up to 7 month visit
Independent scar assessment
Measured: up to month 7
Secondary outcomes (2)
Local tolerability
Measured: up to month 7
Adverse events
Measured: up to month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2007 (estimated)
- Study startMay 2006
- Primary completionJul 2008 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CicatrixStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- D A McGrouther, FRCS MD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432211
- Sponsor's protocol ID
- RN1001-319-1009
- Status last verified
- Feb 2009
- First submitted
- 6 Feb 2007
- Last updated
- 4 Feb 2009
- Results posted
- No
Publications
So K, McGrouther DA, Bush JA, Durani P, Taylor L, Skotny G, Mason T, Metcalfe A, O'Kane S, Ferguson MWJ. Avotermin for scar improvement following scar revision surgery: a randomized, double-blind, within-patient, placebo-controlled, phase II clinical trial. Plast Reconstr Surg. 2011 Jul;128(1):163-172. doi: 10.1097/PRS.0b013e318217429b.
PubMed 21701333
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. 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 Efficacy of Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery.
- ClinicalTrials.gov ID
- NCT00432211
- Acronym / sponsor ID
- RN1001-319-1009
- Conditions
- Cicatrix
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 7 Feb 2007 (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 study is being undertaken to investigate the efficacy and safety of Juvista (given as an intradermal injection of 200ng/100µl per linear centimetre of wound margin) in the prevention or improvement of scar appearance when administered intradermally to approximated wound margins following surgical scar revision.
In addition, this study will compare the scar revision techniques of complete excision (excision of the entire scar during one surgical procedure) and staged excision (excision of the outmost segments and central core separately).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: AvoterminComplete Scar Excision |
| 2 | Placebo comparator | Drug: AvoterminStaged Excision of scar |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects aged 18-85 years who have provided written informed consent.
- A body mass index between 15 and 35 kg/m2 .
- Subjects with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol.
- Female subjects of child bearing potential who are using method(s) of contraception acceptable to the Investigator and agree to do so from at least the screening visit until one month after administration of the final study dose.
- Subjects with linear scars that, in the opinion of the Investigator, are suitable for revision by excision and direct closure. The area of scar to be revised must be at least 5cm in length and have at least two comparable areas.
Key exclusion criteria (15 listed)
- Subjects who on direct questioning and physical examination have history or evidence of keloid scarring.
- Subjects with scars for revision that cross a joint or are in close proximity to an anatomical structure, which could lead to distortion of the resultant scar.
- Subjects with additional scars less than 3cm away from the area to be revised.
- Subjects with a history of a bleeding disorder.
- Subjects with diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerability or efficacy.
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 |
|---|---|---|
| AvoterminComplete Excision:- On Day 0,Following wound closure the two outer segments of the wound will receive either Juvista or placebo.100µl of vehicle containing 200ng of Juvista will be injected per linear centimetre into both margins of one segment of the wound,and 100µl of vehicle alone (placebo) will be injected per linear centimetre into the other segment of the wound. There will be a central area (at least 3cm) of untreated wound between the two segments.The treatments will be re-administered to each wound segment (A and B) 24 hours after the first administration. Staged Excision On Day 0, the two end segments of the scar will be excised.Following wound closure each subject will receive 100µl of vehicle containing 200ng of Juvista per linear centimetre intradermally into one wound, and 100µl of vehicle alone (placebo) per linear centimetre into the other wound.The trial treatments will be re-administered to each wound 24 hours after the first administration. | Drug | 1, 2 |
Primary outcome
Investigator scar assessment
Time frame: up to 7 month visit
Patient scar assessment
Time frame: up to 7 month visit
Independent scar assessment
Time frame: up to month 7
2 secondary outcomes
Local tolerability
Time frame: up to month 7
Adverse events
Time frame: up to month 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
- Derived from this study: PubMed 21701333So K, McGrouther DA, Bush JA, Durani P, Taylor L, Skotny G, Mason T, Metcalfe A, O'Kane S, Ferguson MWJ. Avotermin for scar improvement following scar revision surgery: a randomized, double-blind, within-patient, placebo-controlled, phase II clinical trial. Plast Reconstr Surg. 2011 Jul;128(1):163-172. doi: 10.1097/PRS.0b013e318217429b.
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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.
D A McGrouther, FRCS MD principal investigator
University of Manchester
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 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 6 inclusion and 15 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 4 Feb 2009. 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. Some participants in this study may receive a placebo. 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?
Investigator scar assessment (time frame: up to 7 month visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00432211, which also lists 1 linked publication.
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 4 Feb 2009.