Clinical trial · Interventional
Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| teledermatology feedback | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Feedback group (teledermatology)
- interventionNames
- Other: teledermatology feedback
- type
- NO_INTERVENTION
- label
- Control group (phone only)
Primary outcomes (1)
- 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
- description
- The total exposure to 5-FU will be calculated as total doses over 4 week period.
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDZuo 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 24138974
- BACKGROUNDFox 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 24522259
- BACKGROUNDBrewer 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 24067948
- BACKGROUNDStockfleth 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 25865875
- BACKGROUNDPomerantz 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 25950503
- BACKGROUNDEsmann 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 23215635