Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents

NCT ID: NCT03279328

Last Updated: 2019-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-10

Study Completion Date

2018-07-31

Brief Summary

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This proposed project will be an open-label, split face, randomized controlled pilot study. Up to 60 patients with diffuse facial actinic keratosis will be enrolled in the study. The purpose of this study is to understand the change in skin appearance throughout 5-FU treatment course and to examine whether a topical corticosteroid and moisturizer can decrease severity and duration of skin inflammation after 5-FU treatment course.

Detailed Description

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The purpose of this study to understand the change in skin appearance during and after the course of 5-FU cream in patients with AK, and compare how the appearance of skin inflammation changes with the use of topical corticosteroids and moisturizers.

Conditions

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Actinic Keratoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Topical Steroid Ointment

One side of the face will receive a Topical Steroid ointment twice daily for seven days.

Group Type ACTIVE_COMPARATOR

Topical Steroid Ointment

Intervention Type DRUG

Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.

Vaseline

One side of the face will receive Vaseline twice daily for seven days.

Group Type ACTIVE_COMPARATOR

Vaseline

Intervention Type OTHER

Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.

Skin Barrier Moisturizer

One side of the face will receive Skin Barrier Moisturizer twice daily for seven days.

Group Type ACTIVE_COMPARATOR

Skin Barrier Moisturier

Intervention Type DRUG

Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.

Interventions

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Topical Steroid Ointment

Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.

Intervention Type DRUG

Vaseline

Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.

Intervention Type OTHER

Skin Barrier Moisturier

Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female, at least 18 years of age
* Subject must have a diagnosis of actinic keratosis (at least 5 lesions on each side of the face)
* Able to comprehend and read the English language

* Concurrently have other inflammatory skin conditions.
* Prior known allergy to any components to of 5FU cream, topical steroid ointment or vaseline.

• Subject who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures (i.e.: compliant with using 5-FU cream, topical corticosteroid or moisturizers
* Those that are prisoners or cognitively impaired.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Arizona - Banner University Medicine Dermatology

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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1708724736

Identifier Type: -

Identifier Source: org_study_id

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