Status:
COMPLETED
Investigation of the Safety, Dosing Frequency and Anti-Scarring Potential of Two Concentrations of Intradermal Avotermin (Juvista)
Lead Sponsor:
Renovo
Conditions:
Cicatrix
Wound Healing
Eligibility:
MALE
18-45 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to investigate the dosing frequency, wound healing (re-epithelialisation) and anti-scarring effects of one, three and five applications of two concentrations of intraderma...
Detailed Description
Subjects were randomised into two cohorts, to receive either 5 ng avotermin doses or 50 ng doses, with a minimum of 21 subjects per cohort. Within each cohort subjects were randomised into one of thre...
Eligibility Criteria
Inclusion
- Healthy, non-Caribbean, male subjects aged 18-45 years inclusive
- Weight between 60-150 kg and a BMI within the permitted range for their height using Quetelet's index (15-45 kg/m(squared)) (weight (kg)/height (squared)(m))
- Subjects who have a previous history of surgery or minor injury and who have not developed any evidence of hypertrophic or keloid scar formation
Exclusion
- Subjects who have a history or evidence of hypertrophic or keloid scarring
- Subjects with tattoos or previous scars in the area to be biopsied
- Subjects who have evidence of any past or present clinically significant disease, particularly coagulation disorders
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2002
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00978367
Start Date
February 1 2002
End Date
November 1 2002
Last Update
September 16 2009
Active Locations (1)
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1
Renovo Ltd
Manchester, United Kingdom, M13 9XX