Back to resultsJuvista (Avotermin) in Breast Reduction Surgery Scars
Primary Purpose
Mammaplasty, Cicatrix
Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Avotermin
Sponsored by
About this trial
This is an interventional prevention trial for Mammaplasty
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Fitzwilliam Clinic
- Selly Oak Hospital
- Queen Victoria Hospital
- Royal Victoria Infirmary
- Royal Preston Hospital
- Odstock Centre for Burns & Plastic Surgery, Salisbury District Hospital
Outcomes
Primary Outcome Measures
Investigator scar assessment
Patient scar assessment
Independent scar assessment
Secondary Outcome Measures
Local tolerance
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00432328
Brief Title
Juvista (Avotermin) in Breast Reduction Surgery Scars
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Terminated
Why Stopped
Futility analysis undertaken, determined that study was underpowered.
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Renovo
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mammaplasty, Cicatrix
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Avotermin
Primary Outcome Measure Information:
Title
Investigator scar assessment
Title
Patient scar assessment
Title
Independent scar assessment
Secondary Outcome Measure Information:
Title
Local tolerance
Title
Adverse events
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Gilbert, FDSRCS FRCS
Organizational Affiliation
Queen Victoria Hospital, East Grinstead
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fitzwilliam Clinic
City
Belfast
ZIP/Postal Code
BT9 6AF
Country
United Kingdom
Facility Name
Selly Oak Hospital
City
Birmingham
ZIP/Postal Code
B29 6JD
Country
United Kingdom
Facility Name
Queen Victoria Hospital
City
East Grinstead
ZIP/Postal Code
RH19 3DZ
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Odstock Centre for Burns & Plastic Surgery, Salisbury District Hospital
City
Salisbury
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
12. IPD Sharing Statement
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Juvista (Avotermin) in Breast Reduction Surgery Scars
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