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Skin Tracker: A Mobile Health App to Monitor Skin Disease Activity and Treatment Use

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ClinicalTrials.gov Identifier: NCT04404075
Recruitment Status : Not yet recruiting
First Posted : May 27, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment
Atopic Dermatitis Eczema Other: SkinTracker Mobile App

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.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Skin Tracker: A Mobile Health App to Monitor Skin Disease Activity and Treatment Use
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1 patients
  1. Age 18 and above
  2. Eczema Area and Severity Index (EASI) score ≥ 10
  3. Investigator Global Assessment (IGA) ≥ 3
Other: SkinTracker Mobile App
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
  1. Age 18 and above
  2. Eczema Area and Severity Index (EASI) score ≥ 1 but < 10
  3. Investigator Global Assessment (IGA) 1 or 2
Other: SkinTracker Mobile App
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
  1. Age 12 to 17
  2. Eczema Area and Severity Index (EASI) score ≥ 10
  3. Investigator Global Assessment (IGA) ≥ 3
Other: SkinTracker Mobile App
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
  1. Age 12 to 17
  2. Eczema Area and Severity Index (EASI) score ≥ 1 but < 10
  3. Investigator Global Assessment (IGA) 1 or 2
Other: SkinTracker Mobile App
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Average change in eczema area and severity index EASI score at month 18 [ Time Frame: Month 18 ]
    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

  2. Average change in Investigator global assessment (IGA) at month 6 [ Time Frame: Month 6 ]
    Patient Investigator global assessment (IGA) score will be measured from 9 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

  3. Average change in Investigator global assessment (IGA) at month 18 [ Time Frame: month 18 ]
    Patient Investigator global assessment (IGA) score will be measured from 9 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



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
This is a single-center, observational, pilot study. Ten subjects with atopic dermatitis will be enrolled.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404075


Locations
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United States, California
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Wilson Liao, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04404075    
Other Study ID Numbers: 19-28676
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases