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Sponsored by: |
Organogenesis |
Information provided by: | Organogenesis |
ClinicalTrials.gov Identifier: | NCT00587587 |
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.
Condition | Intervention | Phase |
Keloid |
Device: Apligraf Other: Standard dressing regimen |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | A Prospective, Randomized, Controlled Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids |
Estimated Enrollment: | 30 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
Apligraf (bilayered living cell therapy)
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Device: Apligraf
Application at Day 0, potential re-application at Week 4
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B: Active Comparator
Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
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Other: Standard dressing regimen
A primary nonadherent dressing, dry gauze dressing and bolster gauze dressing if necessary
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |||||
University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology | Recruiting | ||||
Miami Beach, Florida, United States, 33140 | |||||
Contact: Laura Black 305-531-5788 lblack@med.miami.edu | |||||
Principal Investigator: Heather Woolery-Lloyd, MD |
Organogenesis |
Principal Investigator: | Heather Woolery-Lloyd, MD | University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology |
Study Director: | Damien Bates, MD, PhD, FRACS (Plast.) | Organogenesis Inc. |
Responsible Party: | Organogenesis Inc. ( Katherine B. Giovino, Director of Clinical Operations ) |
Study ID Numbers: | 06-KEL-001-AG |
First Received: | December 21, 2007 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00587587 |
Health Authority: | United States: Food and Drug Administration |
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