Status:
COMPLETED
Scar-Improvement Efficacy and Safety of a Single Intradermal Injection of Avotermin (Juvista) Administered Following Full-Thickness Skin Incisions
Lead Sponsor:
Renovo
Conditions:
Cicatrix
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
This study was undertaken to investigate the scar-improvement efficacy and safety of a single dose of avotermin (Juvista) injection into skin incisions.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00627536
Start Date
July 1 2006
End Date
March 1 2007
Last Update
March 4 2008
Active Locations (1)
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1
Renovo Clinical Trials Unit
Manchester, United Kingdom, M139XX