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.
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
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 &
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Month 12 VAs - difference between active and placebo
Jim Bush, MB ChB
Renovo Clinical Trials Unit
United Kingdom: Medicines and Healthcare Products Regulatory Agency