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

NCT00377273 | Completed Phase 4

• 1 other identifier: DL6025-0201
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Interventions

fluorouracil cream 0.5% DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Phyllis Diener, MT, ASCP

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 14, 2006
• First Posted: September 18, 2006
• Study Start: November 1, 2003
• Study Completion: October 1, 2005
• Last Updated: April 10, 2008

Record last verified: 2008-04

Locations

US (1)