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Anti-Scarring Efficacy and Safety of Intradermal Juvista (Avotermin) in Healthy Males

NCT00594581 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2008-01-15

No results posted yet for this study

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.

Conditions

  • Cicatrix

Interventions

DRUG

Juvista (avotermin) plus placebo, standard-care (within-subject controls)

Intradermal Juvista (avotermin) at 50ng or 200ng per 100μl per linear cm of wound margin

Sponsors & Collaborators

  • Renovo

    lead INDUSTRY

Principal Investigators

  • Jim Bush, MBChB · Renovo Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-10-31
Completion
2005-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00594581 on ClinicalTrials.gov