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Clinical Trial Summary

Severe scarring is a common problem following breast reduction surgery, studies have shown that over 64% of patients develop a hypertrophic scar at three months after the operation. Scar severity can be influenced by a large number of factors including age, sex, skin thickness and tension, ethnicity and the position of the scar on the body. Therefore the most sensitive and reliable method to assess the efficacy of an anti-scarring treatment is to compare bilateral wounds on the same individual. Bilateral breast reduction surgery provides an ideal model for a within patient evaluation of anti-scarring activity in wounds which develop into bad scars.

This study is being undertaken to investigate the efficacy and safety of Juvista (given as an intradermal injection of 200ng per 1cm wound margin) in the reduction of scar appearance applied to approximated wound margins following bilateral reduction mammaplasty.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00432328
Study type Interventional
Source Renovo
Contact
Status Terminated
Phase Phase 2
Start date October 2006

See also
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Completed NCT02340325 - FS2 Safety and Tolerability Study in Healthy Volunteers Phase 1
Active, not recruiting NCT00432211 - Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery. Phase 2
Completed NCT00978302 - Safety Study of Repeated, Escalating Doses of Intradermal Avotermin (Juvista) Phase 1
Withdrawn NCT04034615 - The Long-term Effect of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars Phase 2