Status:
COMPLETED
RN1001(Avotermin) in Scar Improvement Following Breast Augmentation
Lead Sponsor:
Renovo
Conditions:
Mammaplasty
Cicatrix
Eligibility:
FEMALE
18-60 years
Phase:
PHASE2
Brief 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. Immediately followin...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00436449
Start Date
December 1 2004
End Date
January 1 2008
Last Update
August 14 2008
Active Locations (7)
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1
The Fitzwilliam Clinic
Belfast, United Kingdom, BT9 6AF
2
The Grosvenor Nuffield Hospital
Chester, United Kingdom, CH4 7QP
3
Classic Hull & East Riding
Hull, United Kingdom, HU10 7AZ
4
Hull Nuffield Hospital
Hull, United Kingdom, HU16 5FQ