Improvement in Scar Appearance Following Injection of Avotermin (Juvista) Into Skin Incisions Made in Healthy Men and Women

February 26, 2008 updated by: Renovo

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

This is a single-centre, double-blind, Placebo-controlled, randomised trial. Trial subjects received four 1cm incisional wounds on the inner aspect of each upper arm (eight in total), giving four pairs of anatomically matched wound sites per subject. Each subject acted as their own control. One site from each anatomical wound pair was randomly treated with intradermally administered avotermin (Juvista:100μL per linear cm of wound site pre-operatively and 100μL per linear cm of wound margin post-wounding on Day 0 or Day 1, 400μL per wound site) while the second site was a paired control, treated with Placebo (100μL per linear cm of wound site pre-operatively and 100μL per linear cm of wound margin post-wounding on Day 0 or Day 1, 400μL per wound site). Wound margins for injection were defined as extending 0.5cm from either end of the incision. Four doses of avotermin (Juvista) were administered to each subject: 5ng, 50ng, 200ng and 500ng/100μL per linear cm; one dose to one wound site per anatomically matched pair of wounds. The second wound site from each anatomically matched pair of wounds was dosed with placebo. Allocation of treatment to wound-site pairs was randomised and double blinded.

Primary objective To determine the optimal concentration and dose regimen of Juvista for the improvement of the resultant scar when applied to the approximated wound margins of male and female subjects following surgical incisions.

Secondary objective To assess the safety and tolerance of Juvista when applied to the approximated wound margins of male and female subjects following surgical incisions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

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
        • Clinical Trials Unit, Renovo

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 have given written informed consent.
  • Subjects with a body mass index within 15-35 kg/m2 (Quetelet's index).

Exclusion Criteria:

  • Subjects with history or evidence of keloid scarring.
  • Subjects with tattoos or previous scars within 3cm of the area to be incised.
  • Subjects who had surgery in the area to be incised within one year of the first dosing day.
  • Subjects with history of a bleeding disorder or who were 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 was chronic or currently active.
  • Subjects with any clinically significant medical condition or history that would impair wound healing.
  • Subjects with history of hypersensitivity to any of the drugs or dressings used in this trial.
  • Subjects taking, or who have taken, any investigational product or who had participated in a clinical trial in the three months prior to first trial dose administration.
  • Subjects 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, methamphetamines, opiates or benzodiazepines during the screening period.
  • Subjects who, in the opinion of the investigator, were unlikely to complete the trial for whatever reason.
  • Subjects who had any 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: PARALLEL
  • Masking: TRIPLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the optimal concentration and dose regimen of avotermim (Juvista) for the improvement of the resultant scar when applied to the approximated wound margins of male and female subjects following surgical incisions.
Time Frame: Post surgery: week 6 to Month 7
Post surgery: week 6 to Month 7

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the safety and tolerance of avotermin (Juvista) when applied to the approximated wound margins of male and female subjects following surgical incisions.
Time Frame: Day 0 (surgery) to Month 7 post surgery
Day 0 (surgery) to Month 7 post surgery

Collaborators and Investigators

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

Sponsor

Renovo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2006

Primary Completion (ACTUAL)

August 1, 2007

Study Completion (ACTUAL)

August 1, 2007

Study Registration Dates

First Submitted

February 26, 2008

First Submitted That Met QC Criteria

February 26, 2008

First Posted (ESTIMATE)

March 6, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2008

Last Update Submitted That Met QC Criteria

February 26, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RN1001-0036

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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