MammaplastyPhase 2NCT00432328
Juvista (Avotermin) in Breast Reduction Surgery Scars
A Phase 2 study testing Avotermin in people with Mammaplasty and Cicatrix, run by Renovo at 6 sites in United Kingdom.
Trial summary
Severe scarring is a common problem following breast reduction surgery, studies have shown that over 64% of patients develop a hypertrophic scar at three months after the operation. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Mammaplasty, Cicatrix
- What is being tested?
- Avotermin
- How many people
- 39 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- Oct 2006to not given
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients between 18 and 65 years of age undergoing bilateral reduction mammaplasty with anchor shaped incisions, who have given written informed consent.
- Patients with a Body Mass Index of 15-32 kg/m2 inclusive.
- Patients 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 1 month after administration of the trial investigational products.
- Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol.
Who cannot join
- Patients with significant breast asymmetry that may result in asymmetrical operative incisions being made on the left and rights breasts.
- Patients with breast asymmetry that may result in different post-operative tensions on the wounds of the left and right breasts.
- Patients who have had surgery in the area to be incised within one year of trial surgery.
- Patients with a history of a bleeding disorder.
- Patients with a history of breast malignancy.
- Patients with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the wounds or involves the areas to be examined in this trial.
Show all 14Show fewer
- Patients who on direct questioning and/or physical examination, have evidence of any past or present clinically significant medical condition that would impair wound healing.
- Patients with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
- Patients who are taking, or have taken, any investigational drugs in the 3 months prior to the screening visit.
- Patients who are taking regular, continuous, oral corticosteroid therapy.
- Patients undergoing investigations or changes in management for an existing medical condition.
- Patients who are or who become pregnant up to and including the day of surgery or who are lactating.
- Patients with diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety or efficacy of the investigational product.
- Patients who, in the opinion of the Investigator, are not likely to complete the trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Fitzwilliam Clinic
Belfast, BT9 6AF
Selly Oak Hospital
Birmingham, B29 6JD
Queen Victoria Hospital
East Grinstead, RH19 3DZ
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Royal Preston Hospital
Preston, PR2 9HT
Odstock Centre for Burns & Plastic Surgery, Salisbury District Hospital
Salisbury, SP2 8BJ
About this study
Official title: A Double Blind, Placebo Controlled, Randomised Trial to Investigate the Efficacy of Juvista (Avotermin) in the Improvement of Scar Appearance in Patients Undergoing Bilateral Reduction Mammaplasty.
Severe scarring is a common problem following breast reduction surgery, studies have shown that over 64% of patients develop a hypertrophic scar at three months after the operation. Scar severity can be influenced by a large number of factors including age, sex, skin thickness and tension, ethnicity and the position of the scar on the body. Therefore the most sensitive and reliable method to assess the efficacy of an anti-scarring treatment is to compare bilateral wounds on the same individual. Bilateral breast reduction surgery provides an ideal model for a within patient evaluation of anti-scarring activity in wounds which develop into bad scars.
This study is being undertaken to investigate the efficacy and safety of Juvista (given as an intradermal injection of 200ng per 1cm wound margin) in the reduction of scar appearance applied to approximated wound margins following bilateral reduction mammaplasty.
- Conditions
- Mammaplasty, 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator scar assessment
Patient scar assessment
Independent scar assessment
Secondary outcomes (2)
Local tolerance
Adverse events
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 startOct 2006
Why it stopped: Futility analysis undertaken, determined that study was underpowered.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammaplastyStudies 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
- Single group
- Masking
- Double blind
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philip Gilbert, FDSRCS FRCS, Principal investigator, Queen Victoria Hospital, East Grinstead
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432328
- Sponsor's protocol ID
- RN1001-0041
- Status last verified
- Jan 2009
- First submitted
- 6 Feb 2007
- Last updated
- 13 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 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 Improvement of Scar Appearance in Patients Undergoing Bilateral Reduction Mammaplasty.
- ClinicalTrials.gov ID
- NCT00432328
- Acronym / sponsor ID
- RN1001-0041
- Conditions
- Mammaplasty, Cicatrix
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility analysis undertaken, determined that study was underpowered.
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- 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.
Severe scarring is a common problem following breast reduction surgery, studies have shown that over 64% of patients develop a hypertrophic scar at three months after the operation. Scar severity can be influenced by a large number of factors including age, sex, skin thickness and tension, ethnicity and the position of the scar on the body. Therefore the most sensitive and reliable method to assess the efficacy of an anti-scarring treatment is to compare bilateral wounds on the same individual. Bilateral breast reduction surgery provides an ideal model for a within patient evaluation of anti-scarring activity in wounds which develop into bad scars.
This study is being undertaken to investigate the efficacy and safety of Juvista (given as an intradermal injection of 200ng per 1cm wound margin) in the reduction of scar appearance applied to approximated wound margins following bilateral reduction mammaplasty.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patients between 18 and 65 years of age undergoing bilateral reduction mammaplasty with anchor shaped incisions, who have given written informed consent.
- Patients with a Body Mass Index of 15-32 kg/m2 inclusive.
- Patients 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 1 month after administration of the trial investigational products.
- Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol.
Key exclusion criteria (14 listed)
- Patients with significant breast asymmetry that may result in asymmetrical operative incisions being made on the left and rights breasts.
- Patients with breast asymmetry that may result in different post-operative tensions on the wounds of the left and right breasts.
- Patients who have had surgery in the area to be incised within one year of trial surgery.
- Patients with a history of a bleeding disorder.
- Patients with a history of breast malignancy.
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 |
|---|---|---|
| Avotermin | Drug | – |
Primary outcome
Investigator scar assessment
Patient scar assessment
Independent scar assessment
2 secondary outcomes
Local tolerance
Adverse events
Results and safety
The study was stopped early (reason given: Futility analysis undertaken, determined that study was underpowered.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2009.
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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.
Philip Gilbert, FDSRCS FRCS principal investigator
Queen Victoria Hospital, East Grinstead
6 sites 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 Mammaplasty and Cicatrix, run by Renovo at 6 sites 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 4 inclusion and 14 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: stopped early, as of the sponsor's last update on 13 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study was stopped early (reason given: Futility analysis undertaken, determined that study was underpowered.). 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. 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?
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 13 Jan 2009.