Clinical trial NCT04404075: Skin Tracker: A Mobile Health App to Monitor Skin Disease Activity and Treatment Use
Official title: Skin Tracker: A Mobile Health App to Monitor Skin Disease Activity and Treatment Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Eczema
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 11
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a single-center, observational, pilot study. Ten subjects with atopic dermatitis will be enrolled.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Ability to provide written informed consent and comply with the protocol.
2. At least 13 years of age.
3. Diagnosis of atopic dermatitis by dermatologist for at least 6 months.
4. Physical exam within clinically acceptable limits.
5. Own or have access to a mobile device that is compatible with study mobile application SkinTracker.

Exclusion Criteria:

1. Subject is unable to provide written informed consent or comply with the protocol.
2. Unable to input data into SkinTracker mobile app.
3. Subject is younger than 13 years of age.
4. Serious known infection.
5. History of immunosuppression (including human immunodeficiency virus (HIV)).
6. 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.
7. Severe concomitant illness.
8. Physical exam not within clinically acceptable limits.
9. Subjects possess other diagnoses that, in the investigator's opinion, preclude him/her from safely participating in this study or interfere

Primary outcomes:
measure: Average change in eczema area and severity index EASI score at month 6
timeFrame: Month 6
Secondary outcomes:
measure: Average change in eczema area and severity index EASI score at month 3
timeFrame: Month 3
measure: Average change in Investigator global assessment (IGA) at month 6
timeFrame: Month 6
measure: Average change in Investigator global assessment (IGA) at month 3
timeFrame: Month 3
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Psoriasis and Skin Treatment Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Wilson Liao, MD
role: PRINCIPAL_INVESTIGATOR
References: