A Trial to Compare the Efficacy of Two Formulations of Avotermin Against Placebo

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01029158

Acronym

RN1006

Enrollment

Registered

2009-12-09

Start date

2009-08-31

Completion date

2010-11-30

Last updated

2010-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scar Improvement

Keywords

Healthy volunteers, Comparison of two formulations, Improvement of scar appearance

Brief summary

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

Interventions

DRUGJuvista (Avotermin)

250 ng, twice, intradermal injection, standard formulation

DRUGRN1006 (Avotermin)

250 ng, intradermal injection, twice

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

* Males and females aged 18-85 years who have given written informed consent * Subjects with a body mass index within range 18-35 kg/m2 * Subjects with clinically acceptable results for the laboratory tests specified in the trial protocol * Female subjects using a highly effective method (S) of contraception

Exclusion criteria

* Subjects who have a history of keloid scarring, surgery within one year of the first dosing area * Subjects who have current scars, tattoos, birthmarks, mole within 3 cm of the area to be excised * Subjects with any clinically significant medical condition or history of any condition which may impair wound healing

Design outcomes

Primary

Measure	Time frame
Global scar comparison scale	12 months

Secondary

Measure	Time frame
Adverse event incidence including specific assessment of local tolerability at the treated wound site	12 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026