Scar-Improvement Efficacy and Safety of a Single Intradermal Injection of Avotermin (Juvista) Administered Following Full-Thickness Skin Incisions

March 3, 2008 updated by: Renovo

A Double-Blind, Placebo-Controlled, Randomised Dose-Ranging Trial to Investigate the Efficacy of Avotermin (Juvista) in the Improvement of Scar Appearance When Applied to Approximated Wound Margins in Healthy Volunteers

This study was undertaken to investigate the scar-improvement efficacy and safety of a single dose of avotermin (Juvista) injection into skin incisions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

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

  • United Kingdom
      • Manchester, United Kingdom, M139XX
        • Renovo Clinical Trials Unit

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females aged 18-85 years who had given written informed consent.
  • Subjects with a body mass index within 15 to 35 kg/m2.
  • Subjects with clinically acceptable results for the laboratory tests
  • Female subjects of child bearing potential who are using acceptable method(s) of contraception.

Exclusion Criteria:

  • Subjects with history or evidence of hypertrophic or keloid scarring.
  • Subjects with tattoos or previous scars within 3cm of the area to be incised.
  • Subjects with prior surgery in the area to be incised within one year of the first dosing day.
  • Subjects with a history of a bleeding disorder; receiving anti-coagulant or anti-platelet therapy.
  • Subjects with evidence of any past or present clinically significant disease that may affect the endpoints of the trial.
  • Subjects with a clinically significant skin disorder that is chronic or currently active.
  • Subjects with any clinically significant medical condition or history that would impair wound healing.
  • Subjects with a history of drug hypersensitivity to any of the drugs or dressings used in this trial.
  • Subjects who are taking, or have taken any investigational product or participated in a clinical trial in the three months prior to first trial dose administration.
  • Subjects who are taking regular, continuous, oral corticosteroid therapy.
  • Subjects undergoing investigations or changes in management for an existing medical condition.
  • Subjects with a history of drug abuse, or with a positive drugs of abuse test for cocaine, amphetamines, metamphetamines, opiates or benzodiazepines during the screening period.
  • Subjects who are considered unlikely to complete the trial for whatever reason.
  • Subjects with a clinically significant neurological impairment or disease.
  • Subjects with any active infection.
  • Subjects who are pregnant or lactating.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
Matched to avotermin dosage strength
Other Names:
  • None applicable
Experimental: 1
Avotermin 5ng/100μL/linear cm wound margin
Drug: Avotermin
A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.
Other Names:
  • Juvista, RN1001, transforming growth factor beta 3
Experimental: 3
Avotermin 50ng/100μL/linear cm wound margin
Drug: Avotermin
A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.
Other Names:
  • Juvista, RN1001, transforming growth factor beta 3
Placebo Comparator: 4
Placebo matched to avotermin 50ng/100μL/linear cm
Drug: Placebo
Matched to avotermin dosage strength
Other Names:
  • None applicable
Experimental: 5
Avotermin 200ng/100μL/linear cm
Drug: Avotermin
A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.
Other Names:
  • Juvista, RN1001, transforming growth factor beta 3
Placebo Comparator: 6
Placebo matched to avotermin 200ng/100μL/linear cm
Drug: Placebo
Matched to avotermin dosage strength
Other Names:
  • None applicable
Experimental: 7
Avotermin 500ng/100μL/linear cm wound margin
Drug: Avotermin
A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.
Other Names:
  • Juvista, RN1001, transforming growth factor beta 3
Placebo Comparator: 8
Placebo matched to avotermin 500ng/100μL/linear cm
Drug: Placebo
Matched to avotermin dosage strength
Other Names:
  • None applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Scar appearance
Time Frame: 7 months
7 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety: adverse events, local tolerability
Time Frame: 7 months
7 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

July 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

February 22, 2008

First Submitted That Met QC Criteria

February 22, 2008

First Posted (Estimate)

March 3, 2008

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RN1001-0050

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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