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

December 4, 2009
December 7, 2010
August 2009
September 2010   (final data collection date for primary outcome measure)
Global scar comparison scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01029158 on ClinicalTrials.gov Archive Site
Adverse event incidence including specific assessment of local tolerability at the treated wound site [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Scar Improvement
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
November 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01029158
RN1006-0100
No
Dr Jim Bush, Renovo
Renovo
Not Provided
Not Provided
Renovo
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP