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

Phase 2

Completed

• Conditions: Cicatrix
• Interventions: Drug: Placebo; Drug: Avotermin

• Registration Number: NCT00627536
• Lead Sponsor: Renovo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Study First Submitted: 2008-02-22
• Study First Submitted QC: 2008-02-22
• Status Verified: 2008-03
• Study First Posted: 2008-03-03
• Last Update Submitted: 2008-03-03
• Last Update Posted: 2008-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
4	Placebo	Placebo matched to avotermin 50ng/100μL/linear cm
6	Placebo	Placebo matched to avotermin 200ng/100μL/linear cm
8	Placebo	Placebo matched to avotermin 500ng/100μL/linear cm
1	Avotermin	Avotermin 5ng/100μL/linear cm wound margin
3	Avotermin	Avotermin 50ng/100μL/linear cm wound margin
5	Avotermin	Avotermin 200ng/100μL/linear cm
7	Avotermin	Avotermin 500ng/100μL/linear cm wound margin

Primary Outcome Measures

Name	Time	Method
Scar appearance	7 months

Secondary Outcome Measures

Name	Time	Method
Safety: adverse events, local tolerability	7 months

Trial Locations

Locations (1)

Renovo Clinical Trials Unit; 🇬🇧 Manchester, United Kingdom