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Juvista (Avotermin) in Breast Reduction Surgery Scars

NCT00432328 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2009-01-13

No results posted yet for this study

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.

Conditions

  • Mammaplasty
  • Cicatrix

Interventions

DRUG

Avotermin

Sponsors & Collaborators

  • Renovo

    lead INDUSTRY

Principal Investigators

  • Philip Gilbert, FDSRCS FRCS · Queen Victoria Hospital, East Grinstead

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00432328 on ClinicalTrials.gov