Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00587587 · ClinicalTrials.gov registry record · Phase 1
A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids
A Phase 1 study, sponsored by Organogenesis.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00587587: Completed Phase 1 study, sponsored by Organogenesis.
NCT00587587 is a Phase 1 study that has completed, run by Organogenesis. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00587587, a Phase 1 study, has completed, sponsored by Organogenesis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
Summary of all reported adverse events (AE) in the intent to treat (ITT) population. AE was defined as any adverse change in the subject's medical status compared with the subject's baseline condition, whether or not the event was related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition. AE data were collected at every study visit or if volunteered by the subject at any time during the study.
Interventions
- DEVICE Apligraf
- OTHER Standard dressing regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-12 |
| Est. Completion | 2010-03 |
| Phase | Phase 1 |
What the finished NCT00587587 record still lists
NCT00587587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Apligraf is the first listed.
NCT00587587 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00587587 about?
NCT00587587 is a clinical study titled "A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids". 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.
What is the current status of trial NCT00587587?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2007-12. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00587587?
The interventions under investigation include: Apligraf (DEVICE), Standard dressing regimen (OTHER).
Who is sponsoring clinical trial NCT00587587?
This trial is sponsored by Organogenesis, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00587587's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia