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

This study has been completed.
Sponsor:
Information provided by:
Renovo
ClinicalTrials.gov Identifier:
NCT00627536
First received: February 22, 2008
Last updated: March 3, 2008
Last verified: March 2008
  Purpose

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


Condition Intervention Phase
Cicatrix
Drug: Avotermin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Renovo:

Primary Outcome Measures:
  • Scar appearance [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: adverse events, local tolerability [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Enrollment: 39
Study Start Date: July 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Juvista, RN1001, transforming growth factor beta 3
Placebo Comparator: 2
Placebo
Drug: Placebo
Matched to avotermin dosage strength
Other Name: None applicable
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: None applicable

  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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627536

Locations
United Kingdom
Renovo Clinical Trials Unit
Manchester, United Kingdom, M139XX
Sponsors and Collaborators
Renovo
Investigators
Principal Investigator: James Bush, MBChB Renovo
  More Information

No publications provided

Responsible Party: Mr Mark Cooper, Senior Vice President of Clinical Operations, Renovo
ClinicalTrials.gov Identifier: NCT00627536     History of Changes
Other Study ID Numbers: RN1001-0050
Study First Received: February 22, 2008
Last Updated: March 3, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Authority

Keywords provided by Renovo:
scarring, Juvista, avotermin, transforming growth factor beta 3, TGFB3

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014