Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents
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ClinicalTrials.gov Identifier: NCT03279328 |
Recruitment Status :
Completed
First Posted : September 12, 2017
Last Update Posted : June 25, 2019
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Condition or disease | Intervention/treatment | Phase |
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Actinic Keratoses | Drug: Topical Steroid Ointment Other: Vaseline Drug: Skin Barrier Moisturier | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents |
Actual Study Start Date : | October 10, 2017 |
Actual Primary Completion Date : | July 31, 2018 |
Actual Study Completion Date : | July 31, 2018 |

Arm | Intervention/treatment |
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Active Comparator: Topical Steroid Ointment
One side of the face will receive a Topical Steroid ointment twice daily for seven days.
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Drug: 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. |
Active Comparator: Vaseline
One side of the face will receive Vaseline twice daily for seven days.
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Other: 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. |
Active Comparator: Skin Barrier Moisturizer
One side of the face will receive Skin Barrier Moisturizer twice daily for seven days.
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Drug: 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. |
- Skin barrier biophysical properties [ Time Frame: 2 hours ]Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring devices (Tewameter)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279328
United States, Arizona | |
University of Arizona - Banner University Medicine Dermatology | |
Tucson, Arizona, United States, 85718 |
Responsible Party: | University of Arizona |
ClinicalTrials.gov Identifier: | NCT03279328 |
Other Study ID Numbers: |
1708724736 |
First Posted: | September 12, 2017 Key Record Dates |
Last Update Posted: | June 25, 2019 |
Last Verified: | June 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Keratosis, Actinic Keratosis Skin Diseases Precancerous Conditions |
Neoplasms Petrolatum Emollients Dermatologic Agents |