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

NCT02616601 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 422

Last updated 2019-07-17

Study results available
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Summary

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.

Conditions

  • Actinic Keratosis

Interventions

DRUG

Generic Fluorouracil Cream

Topical cream, generic formulation of the brand product.

DRUG

Carac® (Fluorouracil) Cream

Topical cream, brand product.

DRUG

Vehicle Cream

Topical cream, placebo. Has no active ingredient.

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Actavis Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-27
Primary Completion
2015-09-17
Completion
2015-09-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02616601 on ClinicalTrials.gov