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| Sponsored by: |
Organogenesis |
|---|---|
| Information provided by: | Organogenesis |
| ClinicalTrials.gov Identifier: | NCT00587587 |
Purpose
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 |
| Enrollment: | 30 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Apligraf (bilayered living cell therapy)
|
Device: Apligraf
Application at Day 0, potential re-application at Week 4
|
|
B: Active Comparator
Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
|
Other: Standard dressing regimen
A primary nonadherent dressing, dry gauze dressing and bolster gauze dressing if necessary
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| University of Miami, Miller School of Medicine, Division of Cosmetic Dermatology | |
| Miami Beach, Florida, United States, 33140 | |
| 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. |
More Information
| Responsible Party: | Organogenesis Inc. ( Katherine B. Giovino, Director of Clinical Operations ) |
| Study ID Numbers: | 06-KEL-001-AG |
| Study First Received: | December 21, 2007 |
| Last Updated: | March 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00587587 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Skin Diseases Collagen Diseases Keloid |
Connective Tissue Diseases Recurrence Cicatrix |
|
Skin Diseases Collagen Diseases Keloid Connective Tissue Diseases Cicatrix |