RN1001(Avotermin) in Scar Improvement Following Breast Augmentation (NCT00436449) | Clinical Trial Compass
CompletedPhase 2
RN1001(Avotermin) in Scar Improvement Following Breast Augmentation
United Kingdom63 participantsStarted 2004-12
Plain-language 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 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.
Who can participate
Age range18 Years – 60 Years
SexFEMALE
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Inclusion Criteria:
* 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 Criteria:
* 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 breas…