Cicatrix Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 71 |
Est. completion date | March 2005 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Clinical Trials Unit, Renovo Ltd | Manchester | La |
Lead Sponsor | Collaborator |
---|---|
Renovo |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Scar appearance | 12 months | No | |
Secondary | Safety: adverse events, local tolerability, systemic exposure | 12 months | Yes |
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