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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00377273
First received: September 14, 2006
Last updated: April 8, 2008
Last verified: April 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Actinic Keratoses
 Drug: fluorouracil cream 0.5%
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The reduction in Actinic Keratosis lesion counts on other body sites from pretreatment to post-treatment and AK clearance of other body site lesions for Treatment Cycle 1.

Secondary Outcome Measures:
  • The reduction in Actinic Keratosis lesion counts of the face (including anterior scalp, if applicable) from pretreatment to post-treatment and AK clearance of facial lesions for each Treatment Cycle
  • The recurrence of facial lesions at 12 and 18 months post initial treatment, and the need for re-treatment.

Estimated Enrollment: 250
Study Start Date: November 2003
Estimated Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377273

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Phyllis Diener, MT, ASCP Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00377273     History of Changes
Other Study ID Numbers: DL6025-0201
Study First Received: September 14, 2006
Last Updated: April 8, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013