Anti-Scarring Efficacy and Safety of Intradermal Juvista (Avotermin) in Healthy Males
Phase 2
Completed
- Conditions
- Cicatrix
- Interventions
- Registration Number
- NCT00594581
- Lead Sponsor
- Renovo
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 71
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Juvista (avotermin) plus placebo, standard-care (within-subject controls) Juvista (avotermin) 50ng/100μl/linear cm wound margin 2 Juvista (avotermin) plus placebo, standard-care (within-subject controls) Juvista (avotermin) at 200ng/100μl/linear cm
- Primary Outcome Measures
Name Time Method Scar appearance 12 months
- Secondary Outcome Measures
Name Time Method Safety: adverse events, local tolerability, systemic exposure 12 months
Trial Locations
- Locations (1)
Clinical Trials Unit, Renovo Ltd
🇬🇧Manchester, La, United Kingdom