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

NCT04404075 | Completed

• 1 other identifier: 19-28676
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Eczema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Average change in eczema area and severity index EASI score at month 3

  Month 3

• Average change in Investigator global assessment (IGA) at month 6

  Month 6

• Average change in Investigator global assessment (IGA) at month 3

  Month 3

Study Arms (4)

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

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

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

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

Interventions

SkinTracker Mobile App OTHER

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 1 patients; Group 2 patients; Group 3 patients; Group 4 patients

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a single-center, observational, pilot study. Ten subjects with atopic dermatitis will be enrolled.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Psoriasis and Skin Treatment Center

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Wilson Liao, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 27, 2020
• Study Start: April 25, 2022
• Primary Completion: May 12, 2023
• Study Completion: May 12, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)