Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis
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ClinicalTrials.gov Identifier: NCT01686152 |
Recruitment Status
:
Completed
First Posted
: September 17, 2012
Last Update Posted
: December 6, 2013
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Sponsor:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Teva Pharmaceuticals USA
Tracking Information | |||
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First Submitted Date ICMJE | September 12, 2012 | ||
First Posted Date ICMJE | September 17, 2012 | ||
Last Update Posted Date | December 6, 2013 | ||
Study Start Date ICMJE | September 2012 | ||
Actual Primary Completion Date | August 2013 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Primary Efficacy Endpoint [ Time Frame: 14 Weeks ] 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | Complete list of historical versions of study NCT01686152 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis | ||
Official Title ICMJE | A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis of the Face or Balding Scalp | ||
Brief 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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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Condition ICMJE | Actinic Keratosis | ||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
589 | ||
Original Estimated Enrollment ICMJE |
588 | ||
Actual Study Completion Date | August 2013 | ||
Actual Primary Completion Date | August 2013 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01686152 | ||
Other Study ID Numbers ICMJE | SYM 2012-01 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Teva Pharmaceuticals USA | ||
Study Sponsor ICMJE | Teva Pharmaceuticals USA | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Teva Pharmaceuticals USA | ||
Verification Date | December 2013 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |