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

Completed · Phase 4

Conditions studied: Actinic Keratoses

In brief

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.

Key facts

Study ID

NCT00377273

Run by

Sanofi

People needed

250

Starts

2003-11-01

Expected to finish

2005-10-01

Last updated by the study team

2008-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sanofi-Aventis — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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