Trials / Completed
CompletedNCT00587587
A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids
A Prospective, Randomized, Controlled Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Organogenesis · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2007-12-01
- Primary completion
- 2010-03-01
- Completion
- 2010-03-01
- First posted
- 2008-01-07
- Last updated
- 2011-08-19
- Results posted
- 2011-08-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00587587. Inclusion in this directory is not an endorsement.