Status:
COMPLETED
Improvement in Scar Appearance Following Injection of Avotermin (Juvista) Into Skin Incisions Made in Healthy Men and Women
Lead Sponsor:
Renovo
Conditions:
Cicatrix
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
This is a single-centre, double-blind, Placebo-controlled, randomised trial. Trial subjects received four 1cm incisional wounds on the inner aspect of each upper arm (eight in total), giving four pair...
Eligibility Criteria
Inclusion
- Males and females aged 18-85 years who have given written informed consent.
- Subjects with a body mass index within 15-35 kg/m2 (Quetelet's index).
Exclusion
- Subjects with history or evidence of keloid scarring.
- Subjects with tattoos or previous scars within 3cm of the area to be incised.
- Subjects who had surgery in the area to be incised within one year of the first dosing day.
- Subjects with history of a bleeding disorder or who were 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 was chronic or currently active.
- Subjects with any clinically significant medical condition or history that would impair wound healing.
- Subjects with history of hypersensitivity to any of the drugs or dressings used in this trial.
- Subjects taking, or who have taken, any investigational product or who had participated in a clinical trial in the three months prior to first trial dose administration.
- Subjects 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, methamphetamines, opiates or benzodiazepines during the screening period.
- Subjects who, in the opinion of the investigator, were unlikely to complete the trial for whatever reason.
- Subjects who had any clinically significant neurological impairment or disease.
- Subjects with any active infection.
- Subjects who are pregnant or lactating.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00629811
Start Date
September 1 2006
End Date
August 1 2007
Last Update
March 6 2008
Active Locations (1)
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1
Clinical Trials Unit, Renovo
Manchester, United Kingdom, M139XX