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Safety and Efficacy Study of Avotermin (Juvista) in Female Subjects

NCT00984581 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2009-09-25

No results posted yet for this study

Summary

To assess safety and toleration, systemic exposure and anti-scarring potential of intradermal avotermin (Juvista) in young females.

Conditions

  • Cicatrix
  • Wound Healing

Interventions

DRUG

Avotermin

Intradermal injection, 5ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6

DRUG

Avotermin

Intradermal injection, 50ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6

DRUG

Placebo

Intradermal injection, 100ul/linear cm wound margin administered on Day 0 and Day 1

Sponsors & Collaborators

  • Renovo

    lead INDUSTRY

Principal Investigators

  • Jonathan Duncan · Renovo

  • Jeremy Bond · Renovo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2004-08-31
Completion
2004-08-31

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 NCT00984581 on ClinicalTrials.gov