Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2017
CompletedFirst Posted
Study publicly available on registry
September 12, 2017
CompletedStudy Start
First participant enrolled
October 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2018
CompletedJune 25, 2019
June 1, 2019
10 months
September 7, 2017
June 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Skin barrier biophysical properties
Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring devices (Tewameter)
2 hours
Study Arms (3)
Topical Steroid Ointment
ACTIVE COMPARATOROne side of the face will receive a Topical Steroid ointment twice daily for seven days.
Vaseline
ACTIVE COMPARATOROne side of the face will receive Vaseline twice daily for seven days.
Skin Barrier Moisturizer
ACTIVE COMPARATOROne side of the face will receive Skin Barrier Moisturizer twice daily for seven days.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arizona - Banner University Medicine Dermatology
Tucson, Arizona, 85718, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2017
First Posted
September 12, 2017
Study Start
October 10, 2017
Primary Completion
July 31, 2018
Study Completion
July 31, 2018
Last Updated
June 25, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share