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
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: 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 July 22, 2014