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Completed Phase 3 Interventional Accepts healthy volunteers Results available

Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis

ClinicalTrials.gov ID: NCT02616601

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.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 9:12 PM EDT

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
Lead sponsor
Actavis Inc.
Industry
Enrollment
422 participants

Conditions and interventions

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 27, 2015 (Actual)
Primary completion
Sep 17, 2015 (Actual)
Completion
Sep 17, 2015 (Actual)
Last update posted
Jul 17, 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 17, 2019 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02616601 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →