A Bioequivalence Study With Clinical Endpoints Comparing Generic Imiquimod Cream, 3.75% and Zyclara™ (Imiquimod) Cream, 3.75% in Subjects With Actinic Keratoses
Public ClinicalTrials.gov record NCT01502020. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of Generic Imiquimod Cream, 3.75% and Zyclara™ (Imiquimod) Cream, 3.75% in Subjects With Actinic Keratoses
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Zyclara™ (imiquimod) Cream, 3.75% is approved by the FDA for the treatment of actinic keratoses on the full face or balding scalp. Zyclara is applied once daily for two, 2-week treatment cycles separated by a 2-week no treatment applied interval. A generic imiquimod cream, 3.75% has been developed by Actavis Mid-Atlantic LLC for the topical treatment of clinically typical, visible or palpable actinic keratoses (AK) of the full face or balding scalp. The current clinical study is designed to evaluate the therapeutic equivalence of this formulation with the currently marketed Zyclara™ (imiquimod) cream, 3.75% formulation (Graceway Pharmaceuticals LLC).
Study identification
- NCT ID
- NCT01502020
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 410 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2011 (Type not available)
- Primary completion
- Aug 2011 (Actual)
- Completion
- Nov 2011 (Actual)
- Last update posted
- Dec 30, 2011
2011
United States locations
- U.S. sites
- 19
- U.S. states
- 16
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center, PC | Birmingham | Alabama | 35205 | — |
| International Dermatology Research, Inc. | Miami | Florida | 33144 | — |
| MedaPhase, Inc. | Newnan | Georgia | 30263 | — |
| Northwest Clinical Trials | Boise | Idaho | 83704 | — |
| Altman Dermatology Associates | Arlington Heights | Illinois | 60005 | — |
| Deaconess Clinic, Inc. | Evansville | Indiana | 47713 | — |
| Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | — |
| Dermatology Specialists | Louisville | Kentucky | 40202 | — |
| Michigan Center for Research Corp. | Clinton Township | Michigan | 48038 | — |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | — |
| Skin Specialists, P.C. | Omaha | Nebraska | 68144 | — |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | — |
| Dermatology, Laser & Vein Specialists of the Carolinas, | Charlotte | North Carolina | 28207 | — |
| Dermatology Research Center of Cincinnati | Cincinnati | Ohio | 45220 | — |
| Oregon Medical Research Center, PC | Portland | Oregon | 97223 | — |
| Philadelphia Institute of Dermatology | Fort Washington | Pennsylvania | 19034 | — |
| DermResearch, Inc. | Austin | Texas | 78759 | — |
| Suzanne Bruce and Associates, P.A. | Houston | Texas | 77056 | — |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01502020, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 30, 2011 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01502020 live on ClinicalTrials.gov.