Juvista (Avotermin) in Scars Following Varicose Vein Removal

Varicose Veins Clinical Trial

Official title:

A Dose Response Trial to Investigate the Efficacy of Juvista (Avotermin) in the Improvement of Scar Appearance When Applied to Approximated Wound Margins Following Bilateral Varicose Vein Removal.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430326
• Other study ID #: RN1001-0042
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2007
• Last updated: March 8, 2010
• Start date: November 2006
• Est. completion date: April 2009

Study information

• Verified date: March 2010
• Source: Renovo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: April 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cicatrix
• Varicose Veins

Intervention

Drug:
• Avotermin

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost Limburg	Genk
Belgium	Universitair Ziekenhuis Gent	Gent
Latvia	P Stradinas Clinical University Hospital	Riga
Lithuania	Kaunas 2nd Clinical Hospital	Kaunas
Lithuania	Klaipeda Seaman Hospital	Klaipeda
Lithuania	Vilnius City University Hospital	Vilnius
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	Heartlands Hospital	Birmingham
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Bristol Royal Infirmary	Bristol
United Kingdom	Derby City General Hospital	Derby
United Kingdom	Russells Hall Hospital	Dudley
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Gloucester Royal Hospital	Gloucester
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	St Georges Hospital	London
United Kingdom	St Mary's Hospital	London
United Kingdom	Wythenshawe Hospital	Manchester
United Kingdom	Freeman Hospital	Newcastle
United Kingdom	Norfolk & Norwich University Hospital	Norwich

Sponsors (2)

Lead Sponsor	Collaborator
Renovo	ICON Clinical Research

Countries where clinical trial is conducted

Belgium,  Latvia,  Lithuania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator scar assessment		7 & 12 months	No
Primary	Patient scar assessment		up to 12 months	No
Primary	Independent scar assessment		7 & 12 months	No
Secondary	Local tolerance		ongoing to 12 months	Yes
Secondary	Adverse events		ongoing to12 months	Yes