Anti-Scarring Efficacy and Safety of Intradermal Juvista (Avotermin) in Healthy Males

A Single-Site, Double-Blind, Phase II Trial to Investigate the Safety, Toleration, Systemic Exposure and Anti-Scarring Potential of Different Applications of Intradermal Juvista (Avotermin) in Male Subjects Aged 18-45 Years

This study was undertaken to investigate safety and scar-improvement activity of different applications of Juvista (avotermin), administered to surgical incisions made to the skin of a healthy population of male volunteers aged 18-45 years. The study addressed two issues: whether Juvista (avotermin) administered at 200ng/100μl/linear cm wound margin is more effective than 50ng/100μl/linear cm for scar improvement and, secondly, whether dosing once only (before wounding) or twice (before and after wounding) is optimal for scar improvement.

Inclusion Criteria:

• Clinically healthy, male subjects aged 18 to 45 years (inclusive)
• Body weight between 40kg and 150kg or a body mass index within the range 15-55kg/m2, calculated using Quetelet's index

Exclusion Criteria:

• Subjects with history or evidence of hypertrophic or keloid scarring, or with tattoos or previous scars in the area to be biopsied.
• Subjects with tattoos or previous scars within 3cm of the area to be incised during the trial.
• Afro-Caribbean volunteers, because of their increased susceptibility to hypertrophic and keloid scarring.
• Subjects who, on direct questioning and physical examination, have evidence of any past or present clinically significant disease.
• Subjects with a chronic or currently active skin disorder, which would adversely affect the healing of the acute wounds or involved the areas to be examined in this trial.
• Subjects with a history of clinically significant allergies.
• Subjects with any clinically significant abnormality following review of pre-trial laboratory data and physical examination.
• Subjects taking, or who had taken, certain prescribed drugs in the 4 weeks before to Day 0 and, in particular, topical or systemic steroids, anti-inflammatory, anti-coagulant, anti-proliferative drugs, and antibiotics.
• Subjects who have taken part in a clinical trial within 3 months before admission to this trial, or who are currently participating in a clinical trial, whether an investigational drug was involved or not.
• Subjects with any clinical evidence of severe ongoing, or prolonged, depression or mental illness.
• Subjects smoking more than 20 cigarettes a day.
• Subjects drinking more than 28 units of alcohol per week (1 unit = ½ pint of beer [285ml], 25ml of spirits, or 1 glass of wine).
• Subjects showing evidence of drug abuse.
• Subjects known to have, or to have had, serum hepatitis or who were carriers of the hepatitis B surface antigen (HbsAg) or hepatitis C antibody.
• Subjects previously testing positive for HIV antibodies, or who admit to belonging to a high-risk group.
• Subjects with pre-existing clinically significant neurological conditions.
• Subjects who, in the opinion of an investigator, are not likely to complete the trial for whatever reason.