Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population

NCT00696488 | Completed Phase 4 Results

• 2 other identifiers: IRB0000015631358
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Fluorouracil 0.5%

EXPERIMENTAL

each subject will receive the study medication: Carac® 0.5% Fluorouracil, a standard treatment for actinic keratoses. Carac® will be dispensed to the subjects in the original tube with MEMS electronic monitoring caps attached. Subjects will be asked to apply the medication daily to AK lesions

Drug: Fluorouracil 0.5%

Interventions

Fluorouracil 0.5% DRUG

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

Also known as: Carac

Fluorouracil 0.5%

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Sciences Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• Yentzer B, Hick J, Williams L, Inabinet R, Wilson R, Camacho FT, Russell GB, Feldman SR. Adherence to a topical regimen of 5-fluorouracil, 0.5%, cream for the treatment of actinic keratoses. Arch Dermatol. 2009 Feb;145(2):203-5. doi: 10.1001/archdermatol.2008.562. No abstract available.

  PMID: 19221274 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Fluorouracil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Steve Feldman, MD
• Organization: Wake Forest University Health Sciences

sfeldman@wakehealth.edu

336-716-3775

Study Officials

• Steve Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2008
• First Posted: June 12, 2008
• Study Start: April 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: October 1, 2008
• Last Updated: September 10, 2018
• Results First Posted: March 27, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)