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NCT00828568 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of Two Imiquimod Cream 5%
A Phase 1 study, sponsored by Sun Pharmaceutical Industries.
- Completed
- Registry status
- Phase 1
- Development phase
- 425
- Enrollment target
NCT00828568: Completed Phase 1 study, sponsored by Sun Pharmaceutical Industries.
NCT00828568 is a Phase 1 study that has completed, run by Sun Pharmaceutical Industries. The registered enrollment target is 425 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (608% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00828568, a Phase 1 study, has completed, sponsored by Sun Pharmaceutical Industries.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 425 participants
- Enrollment target
Study Summary
The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and to show superiority over vehicle in the treatment of AK. The secondary objective is to compare the adverse event (AE) profiles of the two creams.
Primary Outcome
Uses per protocol (PP) population. Each patient is assessed at 24 weeks. Actinic keratosis (AK) lesions that were identified and measured at baseline are reevaluated at the conclusion of the study. If all lesions that were identified at baseline are no longer present and there are no new lesions, the patient is 100% clear of AK lesions.
Interventions
- DRUG Imiquimod 5% manufactured by Taro
- DRUG Aldara - Imiquimod 5%
- DRUG Imiquimod Vehicle manufactured by Taro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 425 participants |
| Start Date | 2008-06 |
| Est. Completion | 2009-05 |
| Phase | Phase 1 |
What the finished NCT00828568 record still lists
NCT00828568 is an interventional study that assigns participants to a tested intervention. The registered 425 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (608% higher).
The record links to 0 conditions, and to 3 interventions - of which Imiquimod 5% manufactured by Taro is the first listed.
NCT00828568 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00828568 about?
NCT00828568 is a clinical study titled "Bioequivalence Study of Two Imiquimod Cream 5%". The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and to show superiority over vehicle in the treatment of AK. The secondary objective is to compare the adverse event...
What is the current status of trial NCT00828568?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 425 participants. The study started on 2008-06. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00828568?
The interventions under investigation include: Imiquimod 5% manufactured by Taro (DRUG), Aldara - Imiquimod 5% (DRUG), Imiquimod Vehicle manufactured by Taro (DRUG).
Who is sponsoring clinical trial NCT00828568?
This trial is sponsored by Sun Pharmaceutical Industries, which has 48 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00828568's enrollment target sits among peer trials
425 65th of 2000 higher than 1,936 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
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