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Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil

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ClinicalTrials.gov Identifier: NCT02938715
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
In this study, subjects who are attending the dermatology clinic and who have already been prescribed topical 5-fluorouracial for the treatment of actinic keratoses as part of their standard of care will be recruited. The purpose of the study is to assess patient satisfaction when engaging in follow up treatment of actinic keratosis via the HIPAA-compliant teledermatology platform called Klara. Additionally, the goal is to assess the difference in total duration of treatment between treatment and control group. A total of 50 subjects will be enrolled and will be randomly assigned into the treatment group (teledermatology group; n=25) or control group (telephone only group; n=25).

Condition or disease Intervention/treatment Phase
Actinic Keratosis Other: teledermatology feedback Not Applicable

Detailed Description:

Objectives

To assess patient satisfaction when engaging in follow up treatment of actinic keratoses: Follow up of subjects with actinic keratoses (AK) who have been prescribed topical 5-fluorouracil (5-FU) therapy as part of their standard of care.

To assess the difference in total dose of exposure to 5-FU between treatment and control group.

Background

Teledermatology is a growing field within dermatology that has started to adapt the use of mobile phone technology (1). The growth of teledermatology has allowed greater access to care in both the inpatient and outpatient setting (1, 2), as well as in educational services (3). The aim of this study is to investigate how mobile phone photographic teledermatology can be adapted for use in the dermatology clinic to continually engage with the patient. More specifically, the researchers seek to understand how mobile phone technology can be used in the evaluation of subjects on topical 5-FU therapy for their actinic keratoses.

Diffuse actinic damage is typically treated with field therapy (4) that involves the use of topical 5-FU. Patients are advised to apply the cream twice daily for 2-4 weeks (5). However, many patients note misunderstanding with these instructions (6). Typical follow up has included telephone based grading and in person follow up (5). However, a return visit to the clinic can be both burdensome to the patient and fill up the clinic with follow up appointments instead of allowing the appointment slot to go to examination of a new patient, thereby reducing access to care for other patients. Telephone conversations are not based on a physical exam and thus do not allow for objective evaluation of the treatment area. For this reason, the researchers seek to use mobile phone photography to evaluate patients with actinic keratoses on topical 5-FU treatment.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil
Actual Study Start Date : October 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Feedback group (teledermatology) Other: teledermatology feedback
subject provided feedback to continue or discontinue their cream (based on actinic keratoses grading and lesion counting)

No Intervention: Control group (phone only)



Primary Outcome Measures :
  1. Difference in total dose of exposure to 5-FU between teledermatology and control group (measured as days of exposure x frequency of application per day) [ Time Frame: 4 weeks ]
    The total exposure to 5-FU will be calculated as total doses over 4 week period.


Secondary Outcome Measures :
  1. Patient satisfaction assessment [ Time Frame: 4 weeks and 8 weeks ]
  2. Change in clinical grading of actinic keratoses [ Time Frame: baseline and weeks 1, 2, 3, 4, 8 ]
  3. Change in AK lesion count [ Time Frame: baseline and weeks 1, 2, 3, 4, 8 ]
  4. Change in severity of symptoms [ Time Frame: baseline and weeks 1, 2, 3, 4, 8 ]
  5. Difference in adverse effects including erythema, pruritus, burning, soreness, and/or tenderness, crusting and/or erosions, scaling and/or flaking, and swelling [ Time Frame: baseline and weeks 1, 2, 3, 4, 8 ]
  6. Difference in number of clinic visits between the 2 groups [ Time Frame: 8 weeks ]


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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:

  • Subjects 18 years of age or older
  • Subjects who have already been prescribed topical 5-fluorouracil for treatment of scalp, facial, arm, or hand actinic keratoses but have not initiated treatment yet

Exclusion Criteria:

  • Adults unable to consent
  • Non English speaking or illiterate
  • Subjects with known allergy to 5-fluorouracil
  • Subjects who do not have access to a smartphone capable of engaging with the online teledermatology platform
  • Pregnant women
  • Prisoners

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): NCT02938715


Locations
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United States, California
UC Davis Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis

Publications:
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02938715     History of Changes
Other Study ID Numbers: 955458
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
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Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs