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

• ClinicalTrials.gov Identifier: NCT00627536
• Recruitment Status: Completed
• First Posted: March 3, 2008
• Last Update Posted: March 4, 2008
• Sponsor: Renovo
• Information provided by: Renovo

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cicatrix	Drug: Avotermin; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, 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
• Study Start Date: July 2006
• Actual Primary Completion Date: March 2007
• Actual Study Completion Date: March 2007

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Scar appearance [ Time Frame: 7 months ]

Secondary Outcome Measures :

1. Safety: adverse events, local tolerability [ Time Frame: 7 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United Kingdom

Renovo Clinical Trials Unit

Manchester, United Kingdom, M139XX

Sponsors and Collaborators

Renovo

Investigators

• Principal Investigator: James Bush, MBChB; Renovo

More Information

• Responsible Party: Mr Mark Cooper, Senior Vice President of Clinical Operations, Renovo
• ClinicalTrials.gov Identifier: NCT00627536
• Other Study ID Numbers: RN1001-0050
• First Posted: March 3, 2008
• Last Update Posted: March 4, 2008
• Last Verified: March 2008

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