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A Trial to Investigate Scar Improvement Efficacy of RN1001 (Avotermin) After Head and Neck Naevi Excision

NCT00656227 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2008-04-11

No results posted yet for this study

Summary

This trial will investigate whether four doses of RN1001 (20ng, 50ng, 100ng and 200ng) are efficacious in preventing or reducing the resultant scar, as compared to placebo, when applied intradermally to wound margins following excision of benign naevi situated on the head and neck.

Conditions

  • Nevus
  • Cicatrix

Interventions

DRUG

Avotermin

Comparison of different dose levels (20ng, 50ng, 100ng or 200ng/100 ul) versus placebo

Sponsors & Collaborators

  • Renovo

    lead INDUSTRY

Principal Investigators

  • Jim Bush, MB ChB · Renovo Clinical Trials Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2007-07-31
Completion
2012-07-31

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 NCT00656227 on ClinicalTrials.gov