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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
63
The Fitzwilliam Clinic
Belfast, United Kingdom
The Grosvenor Nuffield Hospital
Chester, United Kingdom
Classic Hull & East Riding
Hull, United Kingdom
Hull Nuffield Hospital
Hull, United Kingdom
Investigator scar assessment
Patient scar assessment
Independent scar assessment
Local tolerance
Adverse events
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