Atopic DermatitisNCT04404075
Skin Tracker: A Mobile Health App to Monitor Skin Disease Activity and Treatment Use
An observational study of Atopic Dermatitis and Eczema, run by University of California, San Francisco at 1 site in United States.
Trial summary
Design and beta-test a research-oriented mobile health app to assess disease activity, quality of life, treatment patterns, adverse medication effects, and lifestyle factors in patients with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Atopic Dermatitis, Eczema
- What is being tested?
- SkinTracker Mobile App
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2022to 12 May 2023
- Phase
- Observational
- 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 13 years and older
- All sexes
- Child, Adult, Older adult
Study population: This is a single-center, observational, pilot study. Ten subjects with atopic dermatitis will be enrolled.
Who may be able to join
- Ability to provide written informed consent and comply with the protocol.
- At least 13 years of age.
- Diagnosis of atopic dermatitis by dermatologist for at least 6 months.
- Physical exam within clinically acceptable limits.
- Own or have access to a mobile device that is compatible with study mobile application SkinTracker.
Who cannot join
- Subject is unable to provide written informed consent or comply with the protocol.
- Unable to input data into SkinTracker mobile app.
- Subject is younger than 13 years of age.
- Serious known infection.
- History of immunosuppression (including human immunodeficiency virus (HIV)).
- History of malignancy within 5 years prior to screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
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- Severe concomitant illness.
- Physical exam not within clinically acceptable limits.
- Subjects possess other diagnoses that, in the investigator's opinion, preclude him/her from safely participating in this study or interfere
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, 94118
About this study
Design and beta-test a research-oriented mobile health app to assess disease activity, quality of life, treatment patterns, adverse medication effects, and lifestyle factors in patients with atopic dermatitis.
Read the detailed description
Mobile health technology, including smartphone apps and wearable monitors, has tremendous potential to transform clinical research. Recording of patient outcomes on a smartphone device and camera in the home setting can greatly reduce the number of in person research visits, saving tremendous costs, time, and effort associated with data entry. This also allows for easier recruitment of study subjects, who can be enrolled in geographic locations beyond academic research centers. After FDA approval of a therapy, mobile health technology can help researchers understand how that particular therapy is being used in a real-world setting, including frequency of use, adverse events, and impact of use on disease symptoms and patient quality of life. In this study, the investigators will create a mobile app to help the atopic dermatitis community understand the types of data and quality of data that can be gathered from atopic dermatitis patients longitudinally. A review of existing atopic dermatitis mobile apps on the market reveals they are consumer-oriented and may not be able to fully capture high-quality research data. The investigator proposed app is specifically geared for research, and thus fills an important gap. The research team will develop SkinTracker, a research-oriented eczema app to longitudinally track atopic dermatitis severity, symptoms, quality of life, physical activity, medication usage, and adverse events in a real-world setting.
- Conditions
- Atopic Dermatitis, Eczema
- Being tested
- SkinTracker Mobile App
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SkinTracker Mobile AppOther
a research-oriented eczema app to longitudinally track atopic dermatitis severity, symptoms, quality of life, physical activity, medication usage, and adverse events in a real-world setting
| Study group | Role | What they receive |
|---|---|---|
| Group 1 patients | 1. Age 18 and above
2. Eczema Area and Severity Index (EASI) score ≥ 10
3. Investigator Global Assessment (IGA) ≥ 3 Receives: Other: SkinTracker Mobile App | |
| Group 2 patients | 1. Age 18 and above
2. Eczema Area and Severity Index (EASI) score ≥ 1 but < 10
3. Investigator Global Assessment (IGA) 1 or 2 Receives: Other: SkinTracker Mobile App | |
| Group 3 patients | 1. Age 12 to 17
2. Eczema Area and Severity Index (EASI) score ≥ 10
3. Investigator Global Assessment (IGA) ≥ 3 Receives: Other: SkinTracker Mobile App | |
| Group 4 patients | 1. Age 12 to 17
2. Eczema Area and Severity Index (EASI) score ≥ 1 but < 10
3. Investigator Global Assessment (IGA) 1 or 2 Receives: Other: SkinTracker Mobile App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change in eczema area and severity index EASI score at month 6
Patient eczema area and severity index (EASI) will be measured. It is a tool for measuring the amount and severity of eczema a patient has on his or her body, scale is 0-72, 0 means clear and 72 means severe eczema
Measured: Month 6
Secondary outcomes (3)
Average change in eczema area and severity index EASI score at month 3
Patient eczema area and severity index (EASI) will be measured. It is a tool for measuring the amount and severity of eczema a patient has on his or her body, scale is 0-72, 0 means clear and 72 means severe eczema
Measured: Month 3
Average change in Investigator global assessment (IGA) at month 6
Patient Investigator global assessment (IGA) score will be measured from 12 to 18 months, it is a scale to estimate overall severity of eczema but does not take into account BSA specifically, scale is 0 to 4, 0 is clear and 4 is severe
Measured: Month 6
Average change in Investigator global assessment (IGA) at month 3
Patient Investigator global assessment (IGA) score will be measured from 12 to 18 months, it is a scale to estimate overall severity of eczema but does not take into account BSA specifically, scale is 0 to 4, 0 is clear and 4 is severe
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start25 Apr 2022
- Primary completion12 May 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilson Liao, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404075
- Sponsor's protocol ID
- 19-28676
- Status last verified
- Jan 2024
- First submitted
- 21 May 2020
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Tracker: A Mobile Health App to Monitor Skin Disease Activity and Treatment Use
- ClinicalTrials.gov ID
- NCT04404075
- Acronym / sponsor ID
- 19-28676
- Conditions
- Atopic Dermatitis, Eczema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 27 May 2020 (actual)
- 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.
Design and beta-test a research-oriented mobile health app to assess disease activity, quality of life, treatment patterns, adverse medication effects, and lifestyle factors in patients with atopic dermatitis.
Detailed description
Mobile health technology, including smartphone apps and wearable monitors, has tremendous potential to transform clinical research. Recording of patient outcomes on a smartphone device and camera in the home setting can greatly reduce the number of in person research visits, saving tremendous costs, time, and effort associated with data entry. This also allows for easier recruitment of study subjects, who can be enrolled in geographic locations beyond academic research centers. After FDA approval of a therapy, mobile health technology can help researchers understand how that particular therapy is being used in a real-world setting, including frequency of use, adverse events, and impact of use on disease symptoms and patient quality of life. In this study, the investigators will create a mobile app to help the atopic dermatitis community understand the types of data and quality of data that can be gathered from atopic dermatitis patients longitudinally. A review of existing atopic dermatitis mobile apps on the market reveals they are consumer-oriented and may not be able to fully capture high-quality research data. The investigator proposed app is specifically geared for research, and thus fills an important gap. The research team will develop SkinTracker, a research-oriented eczema app to longitudinally track atopic dermatitis severity, symptoms, quality of life, physical activity, medication usage, and adverse events in a real-world setting.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 patients | – | Other: SkinTracker Mobile App1. Age 18 and above 2. Eczema Area and Severity Index (EASI) score ≥ 10 3. Investigator Global Assessment (IGA) ≥ 3 |
| Group 2 patients | – | Other: SkinTracker Mobile App1. Age 18 and above 2. Eczema Area and Severity Index (EASI) score ≥ 1 but < 10 3. Investigator Global Assessment (IGA) 1 or 2 |
| Group 3 patients | – | Other: SkinTracker Mobile App1. Age 12 to 17 2. Eczema Area and Severity Index (EASI) score ≥ 10 3. Investigator Global Assessment (IGA) ≥ 3 |
| Group 4 patients | – | Other: SkinTracker Mobile App1. Age 12 to 17 2. Eczema Area and Severity Index (EASI) score ≥ 1 but < 10 3. Investigator Global Assessment (IGA) 1 or 2 |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- This is a single-center, observational, pilot study. Ten subjects with atopic dermatitis will be enrolled.
Key inclusion criteria (5 listed)
- Ability to provide written informed consent and comply with the protocol.
- At least 13 years of age.
- Diagnosis of atopic dermatitis by dermatologist for at least 6 months.
- Physical exam within clinically acceptable limits.
- Own or have access to a mobile device that is compatible with study mobile application SkinTracker.
Key exclusion criteria (9 listed)
- Subject is unable to provide written informed consent or comply with the protocol.
- Unable to input data into SkinTracker mobile app.
- Subject is younger than 13 years of age.
- Serious known infection.
- History of immunosuppression (including human immunodeficiency virus (HIV)).
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 |
|---|---|---|
| SkinTracker Mobile Appa research-oriented eczema app to longitudinally track atopic dermatitis severity, symptoms, quality of life, physical activity, medication usage, and adverse events in a real-world setting | Other | Group 1 patients, Group 2 patients, Group 3 patients, Group 4 patients |
Primary outcome
Average change in eczema area and severity index EASI score at month 6
Time frame: Month 6
Patient eczema area and severity index (EASI) will be measured. It is a tool for measuring the amount and severity of eczema a patient has on his or her body, scale is 0-72, 0 means clear and 72 means severe eczema
3 secondary outcomes
Average change in eczema area and severity index EASI score at month 3
Time frame: Month 3
Average change in Investigator global assessment (IGA) at month 6
Time frame: Month 6
Average change in Investigator global assessment (IGA) at month 3
Time frame: Month 3
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 25 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Wilson Liao, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Eczema, run by University of California, San Francisco 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 5 inclusion and 9 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 25 Jan 2024. 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?
Average change in eczema area and severity index EASI score at month 6 (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.