Juvista (Avotermin) in Scars Following Varicose Vein Removal - Full Text View

Sponsors and Collaborators:	Renovo ICON Clinical Research
Information provided by:	Renovo
ClinicalTrials.gov Identifier:	NCT00430326

Purpose

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.

Condition	Intervention	Phase
Varicose Veins Cicatrix	Drug: Avotermin	Phase II

MedlinePlus related topics: Scars Varicose Veins

Drug Information available for: Avotermin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
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.

Further study details as provided by Renovo:

Primary Outcome Measures:

Investigator scar assessment [ Time Frame: 7 & 12 months ] [ Designated as safety issue: No ]
Patient scar assessment [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
Independent scar assessment [ Time Frame: 7 & 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Local tolerance [ Time Frame: ongoing to 12 months ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: ongoing to12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	156
Study Start Date:	November 2006
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430326

Locations

Belgium
Ziekenhuis Oost Limburg
Genk, Belgium
Universitair Ziekenhuis Gent
Gent, Belgium
Latvia
P Stradinas Clinical University Hospital
Riga, Latvia
Lithuania
Kaunas 2nd Clinical Hospital
Kaunas, Lithuania
Vilnius City University Hospital
Vilnius, Lithuania
Klaipeda Seaman Hospital
Klaipeda, Lithuania
United Kingdom
Hull Royal Infirmary
Hull, United Kingdom, HU3 2JZ
Derby City General Hospital
Derby, United Kingdom, DE22 3NE
Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Freeman Hospital
Newcastle, United Kingdom, NE7 7DN
Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
St Georges Hospital
London, United Kingdom, SW17 0OT
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
Gloucester Royal Hospital
Gloucester, United Kingdom, GL1 3NN
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8HW
Russells Hall Hospital
Dudley, United Kingdom, DY1 2HQ
St Mary's Hospital
London, United Kingdom, W2 1NY
Norfolk & Norwich University Hospital
Norwich, United Kingdom, NR4 7UY

Sponsors and Collaborators

Renovo

ICON Clinical Research

Investigators

Principal Investigator:

Peter McCollum, MB MCh FRCS

Hull Royal Infirmary

More Information

Responsible Party:	Renovo ( Julia Day, Clinical Trial Manager )
Study ID Numbers:	RN1001-0042
Study First Received:	January 31, 2007
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00430326
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Skin Diseases
Varicose Veins
Vascular Diseases
Cicatrix

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009