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Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population


Phase 4
50 Years
N/A
Not Enrolling
Both
Actinic Keratosis

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Trial Information

Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population


Inclusion Criteria:



- Any male or female 50 years of age or older with moderate to severe actinic keratoses
of the face and anterior scalp diagnosed by a dermatologist will be eligible for
participation.

Exclusion Criteria:

- Age less than 50.

- Known allergy or sensitivity to topical CaracĀ® in the subject.

- Inability to complete all study-related visits.

- Introduction of any other prescription medication, topical or systemic, for actinic
keratosis while participating in the study.

- Subjects should not receive surgical or cryotherapy while participating in the study.

- Pregnant women, women who are breast feeding, or women of child bearing potential who
are not practicing two acceptable methods of birth control

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Adherence to CaracĀ® in subjects with moderate to severe actinic keratosis.

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Steve Feldman, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

00000156

NCT ID:

NCT00696488

Start Date:

April 2007

Completion Date:

October 2008

Related Keywords:

  • Actinic Keratosis
  • Keratosis
  • Keratosis, Actinic

Name

Location

Wake Forest University Health Sciences DermatologyWinston Salem, North Carolina  27157