Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

Actinic Keratosis Clinical Trial

Official title:

Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696488
• Other study ID #: IRB00000156
• Secondary ID: 31358
• Status: Completed
• Phase: Phase 4
• Start date: April 2007
• Est. completion date: October 2008

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to measure adherence to the study drug (Carac) for the treatment of actinic keratoses.

Description:

The purpose of this research study is to measure adherence to the study drug for the treatment of actinic keratoses. The study drug is 5-Fluorouracil (Carac®); it will be used in this study to treat actinic keratoses on the face and anterior scalp. This proposed study will evaluate adherence to topical Carac® in 20 adults age 50 or greater with actinic keratoses from a clinic population. Adherence data will be collected by the MEMS cap (Medication Event Monitoring System

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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 Carac® 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

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Fluorouracil 0.5%
Subjects will apply the smallest amount of study medication possible that is just sufficient to cover all of the affected areas daily to AK lesions

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences Dermatology	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis.	Measure of adherence by MEMS caps and the % of total prescribed doses that were actually used	12 weeks