drugset / Trial / NCT00436449

RN1001(Avotermin) in Scar Improvement Following Breast Augmentation

NCT00436449

Phase 2 Completed 63 enrolled Renovo
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2004-12
Primary completion
2007-10
Completion
2008-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Avotermin Protein / enzyme biologic 50 ng Other
Subject Avotermin Protein / enzyme biologic 200 ng Other

Indications

No indication recorded.