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Completed

NCT Number: NCT02938715

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Department of Dermatology

Sacramento, California, 95816, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

teledermatology feedback

Other

subject provided feedback to continue or discontinue their cream (based on actinic keratoses grading and lesion counting)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 19, 2016
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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