Juvista (Avotermin) in Scars Following Varicose Vein Removal
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|ClinicalTrials.gov Identifier: NCT00430326|
Recruitment Status : Completed
First Posted : February 1, 2007
Last Update Posted : March 9, 2010
|Condition or disease||Intervention/treatment||Phase|
|Varicose Veins Cicatrix||Drug: Avotermin||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||April 2009|
- Investigator scar assessment [ Time Frame: 7 & 12 months ]
- Patient scar assessment [ Time Frame: up to 12 months ]
- Independent scar assessment [ Time Frame: 7 & 12 months ]
- Local tolerance [ Time Frame: ongoing to 12 months ]
- Adverse events [ Time Frame: ongoing to12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430326
|Principal Investigator:||Peter McCollum, MB MCh FRCS||Hull Royal Infirmary|