Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil
|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: NCT02938715|
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : January 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Actinic Keratosis||Other: teledermatology feedback||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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)|
- 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.
- Patient satisfaction assessment [ Time Frame: 4 weeks and 8 weeks ]
- Change in clinical grading of actinic keratoses [ Time Frame: baseline and weeks 1, 2, 3, 4, 8 ]
- Change in AK lesion count [ Time Frame: baseline and weeks 1, 2, 3, 4, 8 ]
- Change in severity of symptoms [ Time Frame: baseline and weeks 1, 2, 3, 4, 8 ]
- 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 ]
- Difference in number of clinic visits between the 2 groups [ Time Frame: 8 weeks ]
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
|United States, California|
|UC Davis Department of Dermatology|
|Sacramento, California, United States, 95816|