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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Renovo
• Treatments: Mitogens

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.