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Phase 4
18 Years
Not Enrolling
Actinic Keratoses

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Trial Information

Inclusion 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.


- 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.


- 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

- 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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

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.

Principal Investigator

Phyllis Diener, MT, ASCP

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2003

Completion Date:

October 2005

Related Keywords:

  • Actinic Keratoses
  • Keratosis
  • Keratosis, Actinic



Sanofi-Aventis Bridgewater, New Jersey  08807