A Trial to Compare the Efficacy of Two Formulations of Avotermin Against Placebo (RN1006)

This study has been completed.

Sponsor:

Information provided by:

Renovo

ClinicalTrials.gov Identifier:

NCT01029158

First received: December 4, 2009

Last updated: December 7, 2010

Last verified: December 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	December 4, 2009
Last Updated Date	December 7, 2010
Start Date ^ICMJE	August 2009
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 7, 2009)	Global scar comparison scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01029158 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 7, 2009)	Adverse event incidence including specific assessment of local tolerability at the treated wound site [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Trial to Compare the Efficacy of Two Formulations of Avotermin Against Placebo
Official Title ^ICMJE	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
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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Condition ^ICMJE	Scar Improvement
Intervention ^ICMJE	Drug: Juvista (Avotermin) 250 ng, twice, intradermal injection, standard formulation Other Names: juvista RN1001 Drug: RN1006 (Avotermin) 250 ng, intradermal injection, twice Other Name: RN1006 Drug: RN1006 (Avotermin) 205 ng, Intradermal injection, once Other Name: RN1006 Drug: RN1006 (Avotermin) 500ng, intradermal injection, once Other Name: RN1006 Drug: Juvista (Avotermin) 250 ng, intradermal injection, twice Other Names: Juvista RN1001 Drug: Juvista (Avotermin) 500 ng, intradermal injection, once Other Names: Juvista RN1001 Drug: RN1006 (Avotermin) 500 ng, intradermal injection, twice Other Name: RN1006 Drug: Placebo Placebo
Study Arm (s)	Experimental: 1a 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. Interventions: Drug: Juvista (Avotermin) Drug: Placebo Experimental: 1b 250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. Interventions: Drug: RN1006 (Avotermin) Drug: Placebo Experimental: 1c 250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Interventions: Drug: RN1006 (Avotermin) Drug: Placebo Experimental: 1d 500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Interventions: Drug: RN1006 (Avotermin) Drug: Placebo Experimental: 2a 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. Interventions: Drug: Juvista (Avotermin) Drug: Placebo Experimental: 2b 500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Interventions: Drug: Juvista (Avotermin) Drug: Placebo Experimental: 2c 500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose. Interventions: Drug: Juvista (Avotermin) Drug: Placebo Experimental: 2d 500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose (i.e. two doses in total). Interventions: Drug: RN1006 (Avotermin) Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	84
Completion Date	November 2010
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01029158
Other Study ID Numbers ^ICMJE	RN1006-0100
Has Data Monitoring Committee	No
Responsible Party	Dr Jim Bush, Renovo
Study Sponsor ^ICMJE	Renovo
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Renovo
Verification Date	December 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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