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NCT00603798 · ClinicalTrials.gov registry record · Phase 3
Safety and Effectiveness Study of Imiquimod Creams for the Treatment of Actinic Keratoses (AKs)
A Phase 3 study, sponsored by Graceway Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 490
- Enrollment target
NCT00603798: Completed Phase 3 study, sponsored by Graceway Pharmaceuticals.
NCT00603798 is a Phase 3 study that has completed, run by Graceway Pharmaceuticals. The registered enrollment target is 490 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00603798, a Phase 3 study, has completed, sponsored by Graceway Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 490 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether imiquimod creams are effective in treating Actinic Keratoses when applied to the face or balding scalp. 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 active ingredient contained in the study cream for this study is the same as that of the approved product Aldara, which has shown to be safe and effective for the treatment of AKs.
Primary Outcome
Subject status with respect to complete clearance of AK lesions at End of Study (EOS), ie, the Week 17 visit. Complete clearance was defined as the absence of clinically visible or palpable AK lesions in the treatment area. All lesions within the identified treatment area were included in the count, even if the lesion was a new lesion or "subclinical" lesion that had not been identified at Baseline.
Interventions
- DRUG Placebo cream
- DRUG Imiquimod cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 490 participants |
| Start Date | 2008-01 |
| Est. Completion | 2008-07 |
| Phase | Phase 3 |
What the finished NCT00603798 record still lists
NCT00603798 is an interventional study that assigns participants to a tested intervention. The registered 490 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo cream is the first listed.
NCT00603798 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00603798 about?
NCT00603798 is a clinical study titled "Safety and Effectiveness Study of Imiquimod Creams for the Treatment of Actinic Keratoses (AKs)". The purpose of this study is to determine whether imiquimod creams are effective in treating Actinic Keratoses when applied to the face or balding scalp. 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, a...
What is the current status of trial NCT00603798?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 490 participants. The study started on 2008-01. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00603798?
The interventions under investigation include: Placebo cream (DRUG), Imiquimod cream (DRUG).
Who is sponsoring clinical trial NCT00603798?
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 NCT00603798's enrollment target sits among peer trials
490 782nd of 2000 higher than 1,218 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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