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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03279328
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arizona

Study Description
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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.

Condition or disease Intervention/treatment Phase
Actinic Keratoses Drug: Topical Steroid Ointment Other: Vaseline Drug: Skin Barrier Moisturier Phase 4

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.
Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Petrolatum

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Topical Steroid Ointment
One side of the face will receive a Topical Steroid ointment twice daily for seven days.
 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.
 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Skin barrier biophysical properties [ Time Frame: 2 hours ]
    Transepidermal water loss (TEWL) will be measured using hand-held, noninvasive skin barrier measuring devices (Tewameter)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Arizona
University of Arizona - Banner University Medicine Dermatology
Tucson, Arizona, United States, 85718
Sponsors and Collaborators
University of Arizona
More Information
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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

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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
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
 Neoplasms
Petrolatum
Emollients
Dermatologic Agents