NCT00656227

A Trial to Investigate Scar Improvement Efficacy of RN1001 (Avotermin) After Head and Neck Naevi Excision

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.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Renovo · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This trial will investigate whether four doses of RN1001 (20ng, 50ng, 100ng and 200ng) are efficacious in preventing or reducing the resultant scar, as compared to placebo, when applied intradermally to wound margins following excision of benign naevi situated on the head and neck.

Detailed description

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)

Conditions

• Nevus
• Cicatrix

Interventions

Type	Name	Description
DRUG	Avotermin	Comparison of different dose levels (20ng, 50ng, 100ng or 200ng/100 ul) versus placebo

Timeline

• Start date: 2004-04-01
• Primary completion: 2007-07-01
• Completion: 2012-07-01
• First posted: 2008-04-11
• Last updated: 2008-04-11

Locations

1 site across 1 country: United Kingdom