MammaplastyPhase 2NCT00436449
RN1001(Avotermin) in Scar Improvement Following Breast Augmentation
A Phase 2 study testing Avotermin in people with Mammaplasty and Cicatrix, run by Renovo at 7 sites in United Kingdom.
Trial summary
This will be a multi-centre, double-blind, within-subject, placebo controlled randomised trial in female subjects. All subjects will undergo bilateral breast augmentation surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Mammaplasty, Cicatrix
- What is being tested?
- Avotermin
- How many people
- 63 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- Dec 2004to Jan 2008
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female subjects between 18 and 60 years of age undergoing bilateral breast augmentation through an infra-mammary fold incision who have given written informed consent.
- 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 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 post surgery.
- Subjects where the same implant position will be used for each breast; the implants can be placed in sub-mammary or sub-pectoral pockets.
- Subjects where the same type and size of implant is to be used for each breast.
- Subjects with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol . All laboratory tests must be performed within 28 days prior to Day 0.
Who cannot join
- Subjects with significant breast asymmetry where this may produce a different length or site of wound, or where there will be a different post-operative tension on the wound.
- Subjects who on direct questioning and physical examination have a history or evidence of hypertrophic or keloid scarring.
- Subjects who have had surgery in the area to be incised within one year of Day 0.
- Subjects with a personal history of a bleeding disorder.
- Subjects with any history of breast malignancy.
- 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.
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- 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 RN1001 within 3 months prior to the screening visit.
- Subjects who are taking regular, continuous, oral corticosteroid therapy.
- 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.
- Subjects with diseases or conditions that could in the opinion of the Investigator interfere with the assessment of safety, tolerability and efficacy.
- In the opinion of the Investigator, a subject who is not likely to complete the trial for what ever reason.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
The Fitzwilliam Clinic
Belfast, BT9 6AF
The Grosvenor Nuffield Hospital
Chester, CH4 7QP
Classic Hull & East Riding
Hull, HU10 7AZ
Hull Nuffield Hospital
Hull, HU16 5FQ
Renovo CTU
Manchester, M13 9XX
BUPA Hospital
Manchester, M16 8AJ
BUPA North Cheshire Hospital
Warrington, WA4 4LU
About this study
Official title: A Double Blind, Within Subject, Placebo Controlled Randomised Trial to Investigate the Scar Improvement Efficacy of a Single Intradermal Application of RN1001 (Avotermin) in Female Subjects Undergoing Bilateral Breast Augmentation
This will be a multi-centre, double-blind, within-subject, placebo controlled randomised trial in female subjects. All subjects will undergo bilateral breast augmentation surgery. Immediately following surgery, each subject will receive 100µl containing 50ng or 200ng of RN1001 per linear centimetre intradermally into both margins of one breast wound, and 100µl of placebo solution per linear centimetre intradermally into both margins of their other breast wound. The allocation of treatment to wound (left or right) will be randomised and double blind.
- 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 posted19 Feb 2007 (estimated)
- Study startDec 2004
- Primary completionOct 2007
- Study completionJan 2008
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Whitby, Principal investigator, BUPA Hospital Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436449
- Sponsor's protocol ID
- RN1001-319-1010
- Status last verified
- Aug 2008
- First submitted
- 16 Feb 2007
- Last updated
- 14 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Within Subject, Placebo Controlled Randomised Trial to Investigate the Scar Improvement Efficacy of a Single Intradermal Application of RN1001 (Avotermin) in Female Subjects Undergoing Bilateral Breast Augmentation
- ClinicalTrials.gov ID
- NCT00436449
- Acronym / sponsor ID
- RN1001-319-1010
- Conditions
- Mammaplasty, Cicatrix
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 19 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 will be a multi-centre, double-blind, within-subject, placebo controlled randomised trial in female subjects. All subjects will undergo bilateral breast augmentation surgery. Immediately following surgery, each subject will receive 100µl containing 50ng or 200ng of RN1001 per linear centimetre intradermally into both margins of one breast wound, and 100µl of placebo solution per linear centimetre intradermally into both margins of their other breast wound. The allocation of treatment to wound (left or right) will be randomised and double blind.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female subjects between 18 and 60 years of age undergoing bilateral breast augmentation through an infra-mammary fold incision who have given written informed consent.
- 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 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 post surgery.
- Subjects where the same implant position will be used for each breast; the implants can be placed in sub-mammary or sub-pectoral pockets.
- Subjects where the same type and size of implant is to be used for each breast.
Key exclusion criteria (14 listed)
- Subjects with significant breast asymmetry where this may produce a different length or site of wound, or where there will be a different post-operative tension on the wound.
- Subjects who on direct questioning and physical examination have a history or evidence of hypertrophic or keloid scarring.
- Subjects who have had surgery in the area to be incised within one year of Day 0.
- Subjects with a personal history of a bleeding disorder.
- Subjects with any 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 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.
David Whitby principal investigator
BUPA Hospital Manchester
7 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 7 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 6 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: finished, as of the sponsor's last update on 14 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 14 Aug 2008.