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NCT01686152 · ClinicalTrials.gov registry record · Phase 3
Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis
A Phase 3 study, sponsored by Teva Pharmaceuticals USA.
- Completed
- Registry status
- Phase 3
- Development phase
- 589
- Enrollment target
NCT01686152: Completed Phase 3 study, sponsored by Teva Pharmaceuticals USA.
NCT01686152 is a Phase 3 study that has completed, run by Teva Pharmaceuticals USA. The registered enrollment target is 589 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01686152, a Phase 3 study, has completed, sponsored by Teva Pharmaceuticals USA.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 589 participants
- Enrollment target
Study Summary
To determine the comparability of the safety and efficacy of Imiquimod Cream, 3.75% and Zyclara (imiquimod) Cream, 3.75% (the reference listed drug) in subjects with actinic keratosis (AK) of the face or balding scalp. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the Vehicle cream.
Primary Outcome
The primary efficacy endpoint is the proportion of subjects with treatment success at Visit 5/Week 14 (8 weeks post-treatment). Treatment success is defined as 100% clearance of all AK lesions (baseline AK lesions and any new AK lesions) within the treatment area.
Interventions
- DRUG Zyclara®
- DRUG Imiquimod Cream, 3.75%
- OTHER Vehicle of Test Product
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 589 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
What the finished NCT01686152 record still lists
NCT01686152 is an interventional study that assigns participants to a tested intervention. The registered 589 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 (24% lower).
The record links to 0 conditions, and to 3 interventions - of which Zyclara® is the first listed.
NCT01686152 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01686152 about?
NCT01686152 is a clinical study titled "Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis". To determine the comparability of the safety and efficacy of Imiquimod Cream, 3.75% and Zyclara (imiquimod) Cream, 3.75% (the reference listed drug) in subjects with actinic keratosis (AK) of the face or balding scalp. It will also be determined whether the efficacy of each of the two active treatme...
What is the current status of trial NCT01686152?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 589 participants. The study started on 2012-09. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01686152?
The interventions under investigation include: Zyclara® (DRUG), Imiquimod Cream, 3.75% (DRUG), Vehicle of Test Product (OTHER).
Who is sponsoring clinical trial NCT01686152?
This trial is sponsored by Teva Pharmaceuticals USA, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01686152's enrollment target sits among peer trials
589 645th of 2000 higher than 1,356 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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