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

December 7, 2010 updated by: Renovo

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Global scar comparison scale
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse event incidence including specific assessment of local tolerability at the treated wound site
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renovo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 4, 2009

First Submitted That Met QC Criteria

December 7, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

December 9, 2010

Last Update Submitted That Met QC Criteria

December 7, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RN1006-0100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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