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

University of Arizona

Status and phase: Completed; Phase 4

Conditions: Actinic Keratoses

Treatments: Drug: Skin Barrier Moisturier; Other: Vaseline; Drug: Topical Steroid Ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT03279328

1708724736

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Subjects who do not fit the inclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Topical Steroid Ointment

Active Comparator group

Description:

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

Treatment:

Drug: Topical Steroid Ointment

Vaseline

Active Comparator group

Description:

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

Treatment:

Other: Vaseline

Skin Barrier Moisturizer

Active Comparator group

Description:

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

Treatment:

Drug: Skin Barrier Moisturier