Clinical trial NCT02938715: Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil
Official title: Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Actinic Keratosis
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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.

Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: 4 weeks
Secondary outcomes:
measure: Patient satisfaction assessment
timeFrame: 4 weeks and 8 weeks
measure: Change in clinical grading of actinic keratoses
timeFrame: baseline and weeks 1, 2, 3, 4, 8
measure: Change in AK lesion count
timeFrame: baseline and weeks 1, 2, 3, 4, 8
measure: Change in severity of symptoms
timeFrame: baseline and weeks 1, 2, 3, 4, 8
measure: Difference in adverse effects including erythema, pruritus, burning, soreness, and/or tenderness, crusting and/or erosions, scaling and/or flaking, and swelling
timeFrame: baseline and weeks 1, 2, 3, 4, 8
measure: Difference in number of clinic visits between the 2 groups
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Department of Dermatology
state: California
Study officials:
References:
citation: Zuo KJ, Guo D, Rao J. Mobile teledermatology: a promising future in clinical practice. J Cutan Med Surg. 2013 Nov-Dec;17(6):387-91. doi: 10.2310/7750.2013.13030.
citation: Fox LP. Practice Gaps. Improving accessibility to inpatient dermatology through teledermatology. JAMA Dermatol. 2014 Apr;150(4):424-5. doi: 10.1001/jamadermatol.2013.9516. No abstract available.
citation: Brewer AC, Endly DC, Henley J, Amir M, Sampson BP, Moreau JF, Dellavalle RP. Mobile applications in dermatology. JAMA Dermatol. 2013 Nov;149(11):1300-4. doi: 10.1001/jamadermatol.2013.5517.
citation: Stockfleth E, Peris K, Guillen C, Cerio R, Basset-Seguin N, Foley P, Sanches J, Culshaw A, Erntoft S, Lebwohl M. A consensus approach to improving patient adherence and persistence with topical treatment for actinic keratosis. Int J Dermatol. 2015;54(5):509-15. doi: 10.1111/ijd.12840. Epub 2015 Apr 10.
citation: Pomerantz H, Hogan D, Eilers D, Swetter SM, Chen SC, Jacob SE, Warshaw EM, Stricklin G, Dellavalle RP, Sidhu-Malik N, Konnikov N, Werth VP, Keri J, Lew R, Weinstock MA; Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group. Long-term Efficacy of Topical Fluorouracil Cream, 5%, for Treating Actinic Keratosis: A Randomized Clinical Trial. JAMA Dermatol. 2015 Sep;151(9):952-60. doi: 10.1001/jamadermatol.2015.0502.
citation: Esmann S, Jemec GB. Patients' perceptions of topical treatments of actinic keratosis. J Dermatolog Treat. 2014 Oct;25(5):375-9. doi: 10.3109/09546634.2012.757285. Epub 2013 Feb 24.