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A prospective randomized comparative clinical trial to evaluate the effectiveness of a digital intervention to reduce atopic symptoms and mental stress in patients with atopic dermatitis

A prospective randomized comparative clinical trial to evaluate the effectiveness of a digital intervention to reduce atopic symptoms and mental stress in patients with atopic dermatitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007127
Enrollment
76
Registered
2022-03-28
Start date
2022-02-21
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : The test group is provided with digital intervention for clinical trials based on cognitive behavioral therapy in the form of an app. The control group is provided with a booklet on a

Sponsors

Yonsei University Health System, Gangnam Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A patient who meets all the selection criteria - Atopic dermatitis patients over the age of 13 - Patients who have no difficulty reading and writing Korean - Patients who have no difficulty using a mobile application using a smartphone - Patients who voluntarily decide to participate and agree in writing to comply with precautions after hearing and understanding sufficient explanation of this clinical trial - Patients who voluntarily agree and can visit for observation

Exclusion criteria

Exclusion criteria: Anyone who falls under any of the exclusion criteria - Those who have difficulty in using surveys and applications without the help of doctor or protector - Those who have not been confirmed to have atopic dermatitis - Those who go against their will - Subjects in critical or vulnerable environments - Those who have difficulty hearing, writing, and speaking Korean - Those who have difficulty using general-purpose equipment - Those who are judged to be non-compliant to participate in this clinical trial - Those who do not understand the purpose and method of this clinical trial, or who are judged to be difficult to conduct this clinical trial by a researcher - Those who are judged to be inappropriate to participate in the clinical trial by the researcher for other reasons

Design outcomes

Primary

MeasureTime frame
Safety;Primary efficacy endpoint: Eczema Area and Severity Index (EASI)

Secondary

MeasureTime frame
Patient-Oriented Eczema Measure(POEM);Hamilton Anxiety Rating Scale (HAM-A);Montgomery-Asberg Depression Rating Scale (MADRS);Quality of life and fear scales (DLQI, CDQI, DFI, and BFNE);Insomnia Severity Index (ISI);Perceived Stress Scale (PSS);Bath and moisturizer use scores

Countries

Korea, Republic of

Contacts

Public ContactJung Yeon Sim

Yonsei University

shimppi@naver.com+82-2-2228-1881

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026