Patients undergoing varicose vein removal with ligation and stripping.
Conditions
Interventions
Product Name: Juvista
Product Code: RN1001
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Avotermin
Current
Sponsors
Renovo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients between 18 and 85 years of age. Patients undergoing surgical removal of bilateral varicose veins by ligation and stripping, which will result in clinically similar (i.e. size and location) wounds at the groin and with exit wounds at either the knee or the ankle. Patients who have provided written informed consent. Patients with a body mass index between 15 and 35kg/m2 inclusive. Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol. Female patients of child bearing potential using method(s) of contraception acceptable to the Investigator and who agree to do so from at least the screening visit until one month after administration of the last dose of IMP. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who have had previous surgical treatment for varicose veins. Paients with a history of a bleeding disorder. Patients with a chronic or currently active skin disorder which may adversely affect the healing of the acute wounds or involves the areas to be examined in this trial. Patients who on direct questioning and/or physical examination, have evidence of any past or present clinically significant medical condition that would impair wound healing. Patients who are taking or have taken investigational drugs in the 3 months prior to the screening visit. Patients with existing scars within 3cm of potential trial wounds. Patients with diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerability or efficacy of the Investigational Product. Patients with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in the trial. 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 who, in the opinion of the Investigator, are not likely to complete the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the dose response efficacy of Juvista in the improvement of scar appearance when applied to the approximated wound margins of patients undergoing surgical removal of varicose veins. ; Secondary Objective: To assess the safety of Juvista when applied to the approximated wound margins of patients following varicose vein surgery. To examine the systemic absorption of Juvista when given intradermally to patients undergoing bilateral varicose vein surgery. ;Primary end point(s): This will be the Total Scar Score (ToScar) of the groin wound from the Independent External Scar Assessment Panel VAS scores at each trial time point up to Month 7. Success will be defined as a statistically significant difference in ToScar between the active and placebo treatments. | — |
Countries
Belgium, Latvia, Lithuania, United Kingdom
Outcome results
None listed