Juvista (Avotermin) in Scars Following Varicose Vein Removal

Phase 2

Completed

• Conditions: Varicose Veins; Cicatrix

• Registration Number: NCT00430326
• Lead Sponsor: Renovo

Brief 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.

Detailed Description

Patients undergoing bilateral removal of the saphenous vein (by ligation and stripping) will be invited to participate in the study. Consenting patients will undergo a detailed screening examination, after which suitability to progress to randomisation to the study will be confirmed.

Suitable screened patients will attend for scheduled surgery of vein removal as normal - this is termed "Day 0" At the time of wound closure, IMP will be administered via intra-dermal injection to each of the incisional groin wounds, and exit wounds.

Each patient will serve as their own control with one leg being administered active IMP (at either a 5, 50, 200 or 500ng/100 ul)of dose solution, whilst the other leg is administered placebo solution. The study is double-blinded, so neither the Investigator nor patient will know which leg wounds receive which treatment.

Further to Day 0, the patients are requested to attend for a further 5 follow up visits (Week 6, Month 3, Month 5, Month 7 \& Month 12), where photographs of the scars will be taken, together with spectrophotometry readings to measure colour of the scar. At each visit, the Investigator and patient will rate their opinion of the scar, by global assessment scale \& VAS, together with patient completed questionnaires.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-01-31
• Study First Submitted QC: 2007-01-31
• Study First Posted: 2007-02-01
• Primary Completion: 2009-01
• Study Completion: 2009-04
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-08
• Last Update Posted: 2010-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Investigator scar assessment	7 & 12 months
Independent scar assessment	7 & 12 months
Patient scar assessment	up to 12 months

Secondary Outcome Measures

Name	Time	Method
Local tolerance	ongoing to 12 months
Adverse events	ongoing to12 months

Trial Locations

Locations (21)

Klaipeda Seaman Hospital; 🇱🇹 Klaipeda, Lithuania

Heartlands Hospital; 🇬🇧 Birmingham, United Kingdom

Derby City General Hospital; 🇬🇧 Derby, United Kingdom

St Mary's Hospital; 🇬🇧 London, United Kingdom

P Stradinas Clinical University Hospital; 🇱🇻 Riga, Latvia

St Georges Hospital; 🇬🇧 London, United Kingdom

Ziekenhuis Oost Limburg; 🇧🇪 Genk, Belgium

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, United Kingdom

Belfast City Hospital; 🇬🇧 Belfast, United Kingdom

Hull Royal Infirmary; 🇬🇧 Hull, United Kingdom

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

Norfolk & Norwich University Hospital; 🇬🇧 Norwich, United Kingdom

Gloucester Royal Hospital; 🇬🇧 Gloucester, United Kingdom

Wythenshawe Hospital; 🇬🇧 Manchester, United Kingdom

Freeman Hospital; 🇬🇧 Newcastle, United Kingdom

Vilnius City University Hospital; 🇱🇹 Vilnius, Lithuania

Kaunas 2nd Clinical Hospital; 🇱🇹 Kaunas, Lithuania

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Bristol Royal Infirmary; 🇬🇧 Bristol, United Kingdom

Russells Hall Hospital; 🇬🇧 Dudley, United Kingdom