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



Status:Completed
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:1/17/2018
Start Date:October 2016
End Date:September 2017

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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).

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.

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
We found this trial at
1
site
Sacramento, California 95816
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mi
from
Sacramento, CA
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