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Safety of Juvista When Administered Following Excision of Ear Lobe Keloids

NCT00710333 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2010-03-09

No results posted yet for this study

Summary

This trial will assess the safety and efficacy of 500ng Juvista per linear cm of wound margin administered by intradermal injection following the excision of keloid scars on the ear lobe. Ear lobe keloids commonly occur after ear piercing and can be particularly distressing for patients as they are very difficult to conceal and are usually bilateral. As the recurrence rate and growth rate of keloids can vary significantly between individuals, trial subjects will have bilateral ear lobe keloids and will act as their own control. One ear lobe will be treated with Juvista following keloid excision and one with placebo.

Conditions

  • Keloid

Interventions

DRUG

Avotermin

10 patients undergoing surgical revision of bilateral keloids will be dosed with 500ng Juvista/100µL per cm of wound margin to one ear lobe and placebo to the other and followed up for three months after dosing to assess the local and systemic tolerability.

DRUG

placebo

placebo

Sponsors & Collaborators

  • Renovo

    lead INDUSTRY

Principal Investigators

  • V V Young, MD · Body Aesthetic Plastic Surgery and Skincare Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-10-31
Completion
2009-12-31

Countries

  • United States

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 NCT00710333 on ClinicalTrials.gov