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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Steroid Ointment | Active Comparator | One side of the face will receive a Topical Steroid ointment twice daily for seven days. |
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| Vaseline | Active Comparator | One side of the face will receive Vaseline twice daily for seven days. |
|
| Skin Barrier Moisturizer | Active Comparator | One side of the face will receive Skin Barrier Moisturizer twice daily for seven days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Steroid Ointment | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin barrier biophysical properties | Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring devices (Tewameter) | 2 hours |
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Inclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona - Banner University Medicine Dermatology | Tucson | Arizona | 85718 | United States |
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| Vaseline | 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. |
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| Skin Barrier Moisturier | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 1, 2021 | Jun 23, 2021 | 3 |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D010577 | Petrolatum |
| ID | Term |
|---|---|
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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