A Double-blind, Placebo Controlled, Randomised Trial to Compare the Efficacy of 250ng and 500ng RN1006 (a New Formulation of Avotermin) and 250ng and 500ng Juvista (Standard Avotermin Formulation), in the Improvement of Scar Appearance in Healthy Volunteer Subjects

NCT01029158 Phase 1 COMPLETED

RN1006 has been developed as a stabilized formulation of avotermin which, when dosed once in pre-clinical studies in animals, has shown comparable scar improvement efficacy to the standard twice-dosed Juvista formulation. The aim of this trial is to investigate the efficacy of RN1006 compared to Juvista in a human volunteer model

Details

Lead sponsor	Renovo
Phase	Phase 1
Status	COMPLETED
Enrolment	84
Start date	2009-08
Completion	2010-11

Conditions

• Scar Improvement

Interventions

• Juvista (Avotermin)
• RN1006 (Avotermin)
• RN1006 (Avotermin)
• RN1006 (Avotermin)
• Juvista (Avotermin)
• Juvista (Avotermin)
• Juvista (Avotermin)
• RN1006 (Avotermin)
• Placebo

Primary outcomes

• Global scar comparison scale — 12 months

Countries

United Kingdom