- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04404075
Skin Tracker: A Mobile Health App to Monitor Skin Disease Activity and Treatment Use
January 23, 2024 updated by: University of California, San Francisco
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
11
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94118
- UCSF Psoriasis and Skin Treatment Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
This is a single-center, observational, pilot study.
Ten subjects with atopic dermatitis will be enrolled.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1 patients
|
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
|
Group 2 patients
|
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
|
Group 3 patients
|
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
|
Group 4 patients
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average change in eczema area and severity index EASI score at month 3
Time Frame: 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
|
Average change in Investigator global assessment (IGA) at month 6
Time Frame: 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
|
Average change in Investigator global assessment (IGA) at month 3
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wilson Liao, MD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 25, 2022
Primary Completion (Actual)
May 12, 2023
Study Completion (Actual)
May 12, 2023
Study Registration Dates
First Submitted
May 21, 2020
First Submitted That Met QC Criteria
May 21, 2020
First Posted (Actual)
May 27, 2020
Study Record Updates
Last Update Posted (Estimated)
January 25, 2024
Last Update Submitted That Met QC Criteria
January 23, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-28676
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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