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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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