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NCT00116649 · ClinicalTrials.gov registry record · Phase 4
Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis
A Phase 4 study, sponsored by Graceway Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 551
- Enrollment target
NCT00116649: Completed Phase 4 study, sponsored by Graceway Pharmaceuticals.
NCT00116649 is a Phase 4 study that has completed, run by Graceway Pharmaceuticals. The registered enrollment target is 551 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00116649, a Phase 4 study, has completed, sponsored by Graceway Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 551 participants
- Enrollment target
Study Summary
Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso, and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The secondary objective is to evaluate the effectiveness of treatment with imiquimod in people with large surface areas of AK.
Primary Outcome
Adverse events that occurred between the first day of exposure to the study cream and study discharge were summarized. Adverse events - any untoward medical occurrence in a subject that is temporally related to protocol procedures, including the administration of a pharmaceutical product at any dose, but which does not necessarily have a causal relationship with the treatment.
Interventions
- DRUG imiquimod cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 551 participants |
| Start Date | 2005-06 |
| Est. Completion | 2007-05 |
| Phase | Phase 4 |
What the finished NCT00116649 record still lists
NCT00116649 is an interventional study that assigns participants to a tested intervention. The registered 551 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which imiquimod cream is the first listed.
NCT00116649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00116649 about?
NCT00116649 is a clinical study titled "Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis". Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treat...
What is the current status of trial NCT00116649?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 551 participants. The study started on 2005-06. Estimated completion is 2007-05.
What interventions are being tested in trial NCT00116649?
The interventions under investigation include: imiquimod cream (DRUG).
Who is sponsoring clinical trial NCT00116649?
This trial is sponsored by Graceway Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00116649's enrollment target sits among peer trials
551 152nd of 2000 higher than 1,849 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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