Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil
1 other identifier
interventional
26
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 17, 2016
CompletedFirst Posted
Study publicly available on registry
October 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedJanuary 16, 2018
January 1, 2018
11 months
October 17, 2016
January 11, 2018
Conditions
Outcome Measures
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)
The total exposure to 5-FU will be calculated as total doses over 4 week period.
4 weeks
Secondary Outcomes (6)
Patient satisfaction assessment
4 weeks and 8 weeks
Change in clinical grading of actinic keratoses
baseline and weeks 1, 2, 3, 4, 8
Change in AK lesion count
baseline and weeks 1, 2, 3, 4, 8
Change in severity of symptoms
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
baseline and weeks 1, 2, 3, 4, 8
- +1 more secondary outcomes
Study Arms (2)
Feedback group (teledermatology)
EXPERIMENTALControl group (phone only)
NO INTERVENTIONInterventions
subject provided feedback to continue or discontinue their cream (based on actinic keratoses grading and lesion counting)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UC Davis Department of Dermatology
Sacramento, California, 95816, United States
Related Publications (6)
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.
PMID: 24138974BACKGROUNDFox 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.
PMID: 24522259BACKGROUNDBrewer 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.
PMID: 24067948BACKGROUNDStockfleth 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.
PMID: 25865875BACKGROUNDPomerantz 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.
PMID: 25950503BACKGROUNDEsmann 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.
PMID: 23215635BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2016
First Posted
October 19, 2016
Study Start
October 1, 2016
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
January 16, 2018
Record last verified: 2018-01