At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
Apligraf +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Controlled Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids
In Brief
A Phase 2 clinical trial evaluating Apligraf and Standard dressing regimen for Keloid. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKeloid
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedJan 2008
Primary CompletionMar 2010
TodayJul 2026
First PostedJan 7, 2008
Enrollment StartDec 1, 2007
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.5 years ago
Interventions
Apligrafdevice
Application at Day 0, potential re-application at Week 4
Standard dressing regimenother
A primary nonadherent dressing, dry gauze dressing and bolster gauze dressing if necessary