A Trial to Investigate Scar Improvement Efficacy of RN1001 (Avotermin) After Head and Neck Naevi Excision
|ClinicalTrials.gov Identifier: NCT00656227|
Recruitment Status : Unknown
Verified April 2008 by Renovo.
Recruitment status was: Active, not recruiting
First Posted : April 11, 2008
Last Update Posted : April 11, 2008
|Condition or disease||Intervention/treatment||Phase|
|Nevus Cicatrix||Drug: Avotermin||Phase 2|
Male and female subjects (aged between 18-85 years) with one or more benign head & neck naevi will be invited to participate in the study.
Each patient will be randomised to a particular dose group, depending on the number of naevi suitable for excision. For example, patients with one excised naevi will receive either a dose of one of the concentrations of RN1001, or placebo. A patient with 2 excised naevi will receive an active dose, and placebo. Patients with 3 excised naevi will receive 2 active doses, plus placebo, and patient with four excised naevi will receive 3 active doses plus placebo.
Naevi will be excised using punch biopsy, and then closed with standard sutures. Following wound closure, the study drug (active RN1001 or placebo) will be administered via intradermal injection at a rate of 100ul per linear cm of wound margin.
Digital and film photography will be taken pre-dose and post dose (Day 0, day 14, day 28, Month 2, 3, 6 & 12, and thereafter at M24, M36, M48 & M60). Additionally, scar assessments (completed by Investigator, Research Nurse & Medical photographer) will be completed at follow up visits from Day 20 onwards. Silicone moulds of the scars will be taken at M6, M12 and then annually to M60.
Patients will be requested to complete a questionnaire to rate their scar expectations/assessment on a total of 5 occasions (screening, Day 0, Month 3, Month 6 & Month 12)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||239 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double Blind, Placebo Controlled Randomised Trial to Investigate the Scar Improvement Efficacy of a Single Intradermal Application of RN1001 (Avotermin) in Subjects Undergoing Excision of Benign Head and Neck Naevi.|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||July 2007|
|Estimated Study Completion Date :||July 2012|
- Drug: Avotermin
Comparison of different dose levels (20ng, 50ng, 100ng or 200ng/100 ul) versus placebo
- Month 12 VAs - difference between active and placebo [ Time Frame: 12 month ]
- VAS from the independent external panel [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656227
|Renovo Clinical Trials Unit|
|Manchester, United Kingdom, M13 9XX|
|Principal Investigator:||Jim Bush, MB ChB||Renovo Clinical Trials Unit|