Status:
TERMINATED
Juvista (Avotermin) in Breast Reduction Surgery Scars
Lead Sponsor:
Renovo
Conditions:
Mammaplasty
Cicatrix
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00432328
Start Date
October 1 2006
Last Update
January 13 2009
Active Locations (6)
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1
Fitzwilliam Clinic
Belfast, United Kingdom, BT9 6AF
2
Selly Oak Hospital
Birmingham, United Kingdom, B29 6JD
3
Queen Victoria Hospital
East Grinstead, United Kingdom, RH19 3DZ
4
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP