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A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids

NCT00587587 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-08-19

Study results available
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Summary

This pilot study will assess the safety and efficacy of Apligraf in the healing and recurrence of keloids post surgical shave excision in patients with clinically diagnosed keloids.

Conditions

  • Keloid

Interventions

DEVICE

Apligraf

Application at Day 0, potential re-application at Week 4

OTHER

Standard dressing regimen

A primary nonadherent dressing, dry gauze dressing and bolster gauze dressing if necessary

Sponsors & Collaborators

  • Organogenesis

    lead INDUSTRY

Principal Investigators

  • Heather Woolery-Lloyd, MD · University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology

  • Damien Bates, MD, PhD, FRACS (Plast.) · Organogenesis Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

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 NCT00587587 on ClinicalTrials.gov