Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis
Public ClinicalTrials.gov record NCT02616601. 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 Fluorouracil Cream, 0.5% and Carac® (Fluorouracil) Cream, 0.5% in Subjects With Actinic Keratoses
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is to evaluate the efficacy and safety of a generic formulation of fluorouracil 0.5% cream against the brand product (Carac) in participants with actinic keratoses.
Study identification
- NCT ID
- NCT02616601
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 422 participants
Conditions and interventions
Conditions
Interventions
- Generic Fluorouracil Cream Drug
- Carac® (Fluorouracil) Cream Drug
- Vehicle Cream Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 26, 2015
- Primary completion
- Sep 16, 2015
- Completion
- Sep 16, 2015
- Last update posted
- Jul 16, 2019
2015
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigative Site 2 | Fremont | California | — | — |
| Investigative Site 16 | Los Angeles | California | — | — |
| Investigative Site 17 | San Diego | California | — | — |
| Investigative Site 4 | Denver | Colorado | — | — |
| Investigative Site 10 | Newnan | Georgia | — | — |
| Investigative Site 5 | Boise | Idaho | — | — |
| Investigative Site 1 | Arlington Heights | Illinois | — | — |
| Investigative Site 11 | Buffalo Grove | Illinois | — | — |
| Investigative Site 3 | Carmel | Indiana | — | — |
| Investigative Site 9 | Plainfield | Indiana | — | — |
| Investigative Site 6 | South Bend | Indiana | — | — |
| Investigative Site 8 | Clinton Township | Michigan | — | — |
| Investigative Site 13 | Warren | Michigan | — | — |
| Investigative Site 12 | Fridley | Minnesota | — | — |
| Investigative Site 15 | Albuquerque | New Mexico | — | — |
| Investigative Site 7 | High Point | North Carolina | — | — |
| Investigative Site 14 | Philadelphia | Pennsylvania | — | — |
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 NCT02616601, 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 Jul 16, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02616601 live on ClinicalTrials.gov.