Back to resultsEvaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents
Primary Purpose
Actinic Keratoses
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Topical Steroid Ointment
Vaseline
Skin Barrier Moisturier
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratoses
Eligibility Criteria
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.
Sites / Locations
- University of Arizona - Banner University Medicine Dermatology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Topical Steroid Ointment
Vaseline
Skin Barrier Moisturizer
Arm Description
One side of the face will receive a Topical Steroid ointment twice daily for seven days.
One side of the face will receive Vaseline twice daily for seven days.
One side of the face will receive Skin Barrier Moisturizer twice daily for seven days.
Outcomes
Primary Outcome Measures
Skin barrier biophysical properties
Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring devices (Tewameter)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03279328
Brief Title
Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents
Official Title
Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical Steroid Ointment
Arm Type
Active Comparator
Arm Description
One side of the face will receive a Topical Steroid ointment twice daily for seven days.
Arm Title
Vaseline
Arm Type
Active Comparator
Arm Description
One side of the face will receive Vaseline twice daily for seven days.
Arm Title
Skin Barrier Moisturizer
Arm Type
Active Comparator
Arm Description
One side of the face will receive Skin Barrier Moisturizer twice daily for seven days.
Intervention Type
Drug
Intervention Name(s)
Topical Steroid Ointment
Intervention Description
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
Intervention Name(s)
Vaseline
Intervention Description
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
Intervention Name(s)
Skin Barrier Moisturier
Intervention Description
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.
Primary Outcome Measure Information:
Title
Skin barrier biophysical properties
Description
Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring devices (Tewameter)
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Arizona - Banner University Medicine Dermatology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents
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