Juvista (Avotermin) in Scars Following Varicose Vein Removal

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is being undertaken to investigate the efficacy and safety of Juvista in the improvement of scar appearance when administered to approximated wound margins following varicose vein surgery. The results from this trial will be used to select doses for investigation in future clinical trials with the compound.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Renovo
• Collaborator: ICON Clinical Research

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 knee.

• Patients who have provided written informed consent.

• Patients with a body mass index between 15 and 35 kg/m2 inclusive.

• Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol (see Protocol Section 6.4.1).

• 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 Investigational Medicinal Product.

Exclusion Criteria:

• Patients who have had previous surgical treatment for varicose veins.

• Patients 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 the 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 this 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.