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Completed

NCT Number: NCT01029158

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

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

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Key information

Conditions

Scar Improvement

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Renovo CTU

Manchester, M13 9XX, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Juvista (avotermin)

Drug

250 ng, twice, intradermal injection, standard formulation

Other names: juvista, RN1001

RN1006 (Avotermin)

Drug

250 ng, intradermal injection, twice

Other names: RN1006

Placebo

Drug

Placebo

Primary outcomes

  1. Global scar comparison scale

    Time frame: 12 months

Secondary outcomes

  1. Adverse event incidence including specific assessment of local tolerability at the treated wound site

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Renovo

Industry

Registry information

Official study title

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

Acronym: RN1006

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 9, 2009
Registry last updated
Dec 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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