Severe scarring following breast reduction surgery.
Conditions
Sponsors
Renovo
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of Juvista in the improvement of scar appearance when applied to the approximated wound margins of female patients undergoing bilateral reduction mammaplasty.;Secondary Objective: To assess the safety of Juvista when applied to the approximated wound margins of subjects following bilateral reduction mammaplasty. To assess the systemic absorption of Juvista when given intradermally to patients undergoing bilateral reduction mammaplasty.;Primary end point(s): The combined Total Scar Score (ToScar) from the Independent External Scar Assessment Panel VAS scores of each trial scar at each trial time point up to Month 7. | — |
Countries
United Kingdom
Outcome results
None listed