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Genomic Changes Associated With the Use of Intradermal Avotermin (Juvista) in Small Wounds in Healthy Male Subjects

NCT00977951 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2009-09-16

No results posted yet for this study

Summary

The purpose of this study is to further determine the safety and toleration of intradermal avotermin (Juvista), confirm accelerated healing and investigate genomic expression profiles

Conditions

  • Cicatrix
  • Wound Healing

Interventions

DRUG

Intradermal avotermin

50 ng/100 ul avotermin administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 3 and again on day 4

DRUG

Intradermal avotermin

50 ng/100 ul avotermin administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 5 and again on day 6

DRUG

Placebo (vehicle)

Placebo administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 3 and again on day 4

DRUG

Placebo

50 ng/100 ul avotermin administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 5 and again on day 6

Sponsors & Collaborators

  • Renovo

    lead INDUSTRY

Principal Investigators

  • Michael J Davies · Renovo

  • Jonathan Duncan · Renovo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2003-09-30
Completion
2003-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT00977951 on ClinicalTrials.gov