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
  Purpose

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 Intervention Phase
Scar Improvement
Drug: Juvista (Avotermin)
Drug: RN1006 (Avotermin)
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Renovo:

Primary Outcome Measures:
  • Global scar comparison scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event incidence including specific assessment of local tolerability at the treated wound site [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 84
Study Start Date: August 2009
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029158

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

No publications provided

Responsible Party: Dr Jim Bush, Renovo
ClinicalTrials.gov Identifier: NCT01029158     History of Changes
Other Study ID Numbers: RN1006-0100
Study First Received: December 4, 2009
Last Updated: December 7, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on October 19, 2014