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

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ClinicalTrials.gov Identifier: NCT01029158
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : December 9, 2010
Sponsor:
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Scar Improvement Drug: Juvista (Avotermin) Drug: RN1006 (Avotermin) Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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
Study Start Date : August 2009
Primary Completion Date : September 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars
Drug Information available for: Avotermin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Drug: Juvista (Avotermin)
250 ng, twice, intradermal injection, standard formulation
Other Names:
  • juvista
  • RN1001
Drug: Placebo
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.
Drug: RN1006 (Avotermin)
250 ng, intradermal injection, twice
Other Name: RN1006
Drug: Placebo
Placebo
Experimental: 1c
250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
Drug: RN1006 (Avotermin)
205 ng, Intradermal injection, once
Other Name: RN1006
Drug: Placebo
Placebo
Experimental: 1d
500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
Drug: RN1006 (Avotermin)
500ng, intradermal injection, once
Other Name: RN1006
Drug: Placebo
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.
Drug: Juvista (Avotermin)
250 ng, intradermal injection, twice
Other Names:
  • Juvista
  • RN1001
Drug: Placebo
Placebo
Experimental: 2b
500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
Drug: Juvista (Avotermin)
500 ng, intradermal injection, once
Other Names:
  • Juvista
  • RN1001
Drug: Placebo
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.
Drug: Juvista (Avotermin)
500 ng, intradermal injection, once
Other Names:
  • Juvista
  • RN1001
Drug: Placebo
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).
Drug: RN1006 (Avotermin)
500 ng, intradermal injection, twice
Other Name: RN1006
Drug: Placebo
Placebo


Outcome Measures

Primary Outcome Measures :
  1. Global scar comparison scale [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Adverse event incidence including specific assessment of local tolerability at the treated wound site [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029158


Locations
United Kingdom
Renovo CTU
Manchester, United Kingdom, M13 9XX
Sponsors and Collaborators
Renovo
More Information

Responsible Party: Dr Jim Bush, Renovo
ClinicalTrials.gov Identifier: NCT01029158     History of Changes
Other Study ID Numbers: RN1006-0100
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: December 9, 2010
Last Verified: December 2010

Keywords provided by Renovo:
Healthy volunteers
Comparison of two formulations
Improvement of scar appearance