An Open-Label 18-Month Safety Study of Fluorouracil Cream 0.5% for the Treatment of Actinic Keratoses

NCT ID: NCT00377273

Last Updated: 2008-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2005-10-31

Brief Summary

This study is being undertaken to: 1. assess the safety of fluorouracil cream for the treatment of actinic keratoses ("AKs") on other common skin surface areas (e.g., posterior scalp, ears, neck, lips, arms and hands); 2. collect additional post-treatment safety data on fluorouracil cream applied to the face (including anterior scalp, if applicable); 3. assess the incidence of recurrence of AKs on the face; and 4. assess the need for re-treatment with fluorouracil cream to the face.

Conditions

Actinic Keratoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

fluorouracil cream 0.5%

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients must give written informed consent;
• Patients must have at least 5 visible and/or palpable AKs on the posterior scalp, ears, neck, lips, arms and/or hands (across all other body sites) and an additional 5 visible and/or palpable AKs on the face (including anterior scalp, if applicable);
• Female patients must be post-menopausal for at least one year, or have had a hysterectomy, or have had a tubal ligation, or use oral/systemic contraceptives, an intrauterine device (IUD) or Norplant starting at least 28 days prior to study entry and throughout the study. Female patients of childbearing potential must have a negative urine pregnancy test prior to the first application of test medication
• Patients must be compliant and willing to return to the study site for designated follow-up visits.

Exclusion Criteria

• Pregnant or lactating females;
• Patients with a current skin condition on the face, scalp, ears, neck, lips, arms and/or hands that could confound the study, including basal cell and squamous cell carcinomas;
• Patients with a known allergy to any ingredients of the test drug formulations;
• Patients with known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency;
• Patients whose activities involve excessive or prolonged exposure to sunlight;
• Patients who use a tanning parlor;
• Patients treated with other topical agents for the treatment of actinic keratosis in the designated treatment area within 5 months prior to the start of the study are prohibited;
• Patients who have had liquid nitrogen treatment for AKs within 4 weeks prior to study start in the designated treatment area;
• History of drug or alcohol abuse.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Principal Investigators

Phyllis Diener, MT, ASCP

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Bridgewater, New Jersey, United States

Countries

United States

Other Identifiers

DL6025-0201

Identifier Type: -

Identifier Source: org_study_id