A double blind, placebo controlled, randomised trial to investigate the efficacy of Juvista in the improvement of scar appearance in patients undergoing bilateral reduction mammaplasty. - Juvista in breast reductio

• Conditions: Severe scarring following breast reduction surgery.

• Registration Number: EUCTR2005-004265-42-GB
• Lead Sponsor: Renovo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 39

Inclusion Criteria

Female patients, aged 18-65 with a BMI of 15-32.
Patients of child-bearing potential using acceptable method(s) of contraception
Patients with clinically acceptable laboratory results for laboratory tests specified in the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with significant breast asymmetry
Patients who have had previous surgery in the area to be excised within 1 year
Patients with a history of a bleeding disorder
Patients with a history of breast malignancy
Patient with a chronic or currently active skin disorder
Patients with a clinically significant medical condition that would impair healing.
Patients with hypersensitivity to drug or dressings in the trial
Patients who are taking or have taken any investigational drugs in 3 months prior to screening.
Patients who are taking regular, continuous, oral corticosteroid therapy.
Patients undergoing investigations or changes in management for an existing medical condition.
Patients who are pregnant or lactating.
Patients with diseases or conditions that could interfere with the assessment of safety or efficacy of the IMP.
Patients who are not likely to complete the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified