Actinic KeratosisNCT02938715
Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil
A study testing teledermatology feedback in people with Actinic Keratosis, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- teledermatology feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Department of Dermatology
Sacramento, California, 95816
About this study
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).
Read the 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.
- Conditions
- Actinic Keratosis
- Being tested
- teledermatology feedback
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teledermatology feedbackOther
subject provided feedback to continue or discontinue their cream (based on actinic keratoses grading and lesion counting)
| Study group | Role | What they receive |
|---|---|---|
| Feedback group (teledermatology) | Experimental | Not described Receives: Other: teledermatology feedback |
| Control group (phone only) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (6)
Patient satisfaction assessment
Measured: 4 weeks and 8 weeks
Change in clinical grading of actinic keratoses
Measured: baseline and weeks 1, 2, 3, 4, 8
Change in AK lesion count
Measured: baseline and weeks 1, 2, 3, 4, 8
Change in severity of symptoms
Measured: 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
Measured: baseline and weeks 1, 2, 3, 4, 8
Difference in number of clinic visits between the 2 groups
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938715
- Sponsor's protocol ID
- 955458
- Status last verified
- Jan 2018
- First submitted
- 17 Oct 2016
- Last updated
- 16 Jan 2018
- Results posted
- No
Publications
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.
PubMed 24138974Fox 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.
PubMed 24522259Brewer 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.
PubMed 24067948Stockfleth 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.
PubMed 25865875Pomerantz 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.
PubMed 25950503Esmann 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.
PubMed 23215635
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil
- ClinicalTrials.gov ID
- NCT02938715
- Acronym / sponsor ID
- 955458
- Conditions
- Actinic Keratosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback group (teledermatology) | Experimental | Other: teledermatology feedback |
| Control group (phone only) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| teledermatology feedbacksubject provided feedback to continue or discontinue their cream (based on actinic keratoses grading and lesion counting) | Other | Feedback group (teledermatology) |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Background: PubMed 24138974Zuo 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.
- Background: PubMed 24522259Fox 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.
- Background: PubMed 24067948Brewer 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.
- Background: PubMed 25865875Stockfleth 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.
- Background: PubMed 25950503Pomerantz 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.
- Background: PubMed 23215635Esmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing teledermatology feedback in people with Actinic Keratosis, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02938715, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.