Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis
Public ClinicalTrials.gov record NCT00948428. 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, Double-Blind, Randomized, Parallel Group, Vehicle-Controlled Study to Determine the Clinical Equivalence of a Generic Imiquimod Cream, 5% and Aldara™ Cream in Subjects With Actinic Keratosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
At the end of the study, safety and efficacy outcome measures will be compared to determine a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently marketed Aldara (imiquimod) cream, 5% and b) if both imiquimod 5% creams are superior in comparison to the Vehicle cream.
Study identification
- NCT ID
- NCT00948428
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 462 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
- Apr 30, 2008
- Primary completion
- Feb 28, 2009
- Completion
- Mar 31, 2009
- Last update posted
- Sep 3, 2020
2008 – 2009
United States locations
- U.S. sites
- 20
- U.S. states
- 15
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | — |
| Associates in Research, Inc. | Fresno | California | 93720 | — |
| Skin Surgery Medical Group, Inc. | San Diego | California | 92117 | — |
| Cherry Creek Research, Inc. | Denver | Colorado | 80209 | — |
| FXM Research Corp. | Miami | Florida | 33175 | — |
| MedaPhase, Inc. | Newnan | Georgia | 30263 | — |
| Deaconess Clinic, Inc. | Evansville | Indiana | 47713 | — |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | — |
| Mt. Sinai School of Medicine | New York | New York | 10029 | — |
| Derm Research Center of New York, Inc. | Stony Brook | New York | 11790 | — |
| University Dermatology Consultants, Inc. | Cincinnati | Ohio | 45219 | — |
| Oregon Medical Research Center, P.C. | Portland | Oregon | 97223 | — |
| Rhode Island Hospital, Dermatopharmacology Division | Providence | Rhode Island | 02903 | — |
| Dermatology Associates of Knoxville, P.C. | Knoxville | Tennessee | 37917 | — |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | — |
| DermResearch, Inc. | Austin | Texas | 78759 | — |
| Suzanne Bruce & Associates, P.A. | Houston | Texas | 77056 | — |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | — |
| Dermatology Research Center, Inc. | Salt Lake City | Utah | 84124 | — |
| Premier Clinical Research | Spokane | Washington | 99204 | — |
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 NCT00948428, 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 Sep 3, 2020 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00948428 live on ClinicalTrials.gov.