Atopic Dermatitis Clinical Trial
Official title:
Skin Tracker: A Mobile Health App to Monitor Skin Disease Activity and Treatment Use
NCT number | NCT04404075 |
Other study ID # | 19-28676 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 25, 2022 |
Est. completion date | May 12, 2023 |
Verified date | January 2024 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | May 12, 2023 |
Est. primary completion date | May 12, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 13 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UCSF Psoriasis and Skin Treatment Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Month 6 | |
Secondary | 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 | Month 3 | |
Secondary | 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 | Month 6 | |
Secondary | 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 | Month 3 |
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