NCT00587223

Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB)

A Prospective, Multicenter, Within Subject Controlled Study to Evaluate the Effect of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Organogenesis · Industry
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the use of Apligraf for the treatment of nonhealing wounds in subjects with dystrophic or junctional epidermolysis bullosa. Apligraf will be evaluated for efficacy and safety compared to a conventional nonadherent dressing. A matched-pair design will be used to evaluate Apligraf treatment versus conventional treatment in 68 study pairs.

Conditions

• Epidermolysis Bullosa, Junctional
• Epidermolysis Bullosa Dystrophica

Interventions

Type	Name	Description
DEVICE	Apligraf	Up to 3 applications: Day 0, Month 1, Month 2.
OTHER	Standard dressing regimen	Dressing regimen will be comprised of a primary nonadherent dressing, nonstick gauze and standard dressing retainer

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-01-07
• Last updated: 2010-06-29
• Results posted: 2010-06-22

Locations

5 sites across 1 country: United States