NCT00436449

RN1001(Avotermin) in Scar Improvement Following Breast Augmentation

A Double Blind, Within Subject, Placebo Controlled Randomised Trial to Investigate the Scar Improvement Efficacy of a Single Intradermal Application of RN1001 (Avotermin) in Female Subjects Undergoing Bilateral Breast Augmentation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Renovo · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mammaplasty
• Cicatrix

Interventions

Type	Name	Description
DRUG	Avotermin

Timeline

• Start date: 2004-12-01
• Primary completion: 2007-10-01
• Completion: 2008-01-01
• First posted: 2007-02-19
• Last updated: 2008-08-14

Locations

7 sites across 1 country: United Kingdom