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Thymalin

Thymulin, Thymic Factor, Serum Thymic Factor, Facteur Thymique Serique

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Studies 202
Trials 37
Unknown NA INTERVENTIONAL NCT05502848

The Effect of Intervention and Mechanism of ICBT on Chronic Itching in Patients With Atopic Dermatitis

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Objectives: The study subjects were 180 healthy people from the dermatology clinic of Xiangya Hospital of Central South University and the surroundingcommunity, including 120 AD patients (60 in the ICBT treatment group and 60 in the control group) and 60 healthy controls. Methodology: After obtaining the informed consent of the subjects, the general condition and clinical symptoms of the subjects were assessed, the cognitive and psychological characteristics of the subjects who met the inclusion were assessed, multimodality MRI was scanned and blood and saliva samples were collected. The same assessments and data collection were performed with healthy controls matched for age, sex, and years of education in the AD patient group. AD patients were randomly assigned to the ICBT intervention group (n = 60) by a random number table and immediately started ICBT adjuvant therapy, or the control group (n = 60) for conventional therapy. Clinical symptoms and cognitive psychological characteristics of AD patients were assessed at the end of 2 weeks, 4 weeks, 8 weeks, 6 months and 12 months of ICBT treatment, and cognitive behavioral task measurements, multimodality magnetic resonance scans, blood and saliva samples will be performed again at the follow-up time point at the end of 6 months. Healthy controls (60) will also undergo a full set of follow-up assessments again after 6 months.

Detailed Description

Atopic dermatitis (AD) is a common chronic inflammatory skin disease accompanied by severe itching, leading to poor patient-reported satisfaction. Previous studies have found a mutually reinforcing relationship between stress, depression, anxiety and itching in AD, which is mediated by cognitive dysfunction. Patients with AD show elevated activation in the key regions of cognitive control network, such as anterior cingulate cortex and dorsolateral prefrontal cortex, when facing itching stimulus, which are positively associated with the severity of itching. Based on these findings, we propose a hypothesis that "dysfunction of cognitive control network may underlie the increased sensitivity to itching in AD". To test the hypothesis, we will conduct a randomized controlled study on the effectiveness of Internet cognitive behavior therapy (ICBT) for AD. Using the multi-modal magnetic resonance imaging technology, we will compare the brain imaging characteristics in AD patients before and after treatment with ICBT. We will further investigate the factors associated with response to ICBT treatment and the underlying mechanisms of the treatment effect of ICBT, expecting to improve long-term treatment outcomes of AD.

Interventions

Name: Internet Cognitive Behavior Therapy
Type: BEHAVIORAL
Description: ICBT helps change patterns of thinking (cognitions) and behaviors of psychological distress, including relaxation, stress management, while using ICBT can increase personal tolerance for negative thoughts and negative emotions, help patients reduce negative perception of the disease due to long-term recurrent itching, and break the vicious cycle

Primary Outcomes

Measure: Change from Baseline on the Patient Oriented Eczema Measure(POEM)
TimeFrame: Baseline and Week 2;4;8 and Month 6;12
Description: Patient Oriented Eczema Measure (POEM) is divided into 7 questions, with a total score of 28 points, and treatment response is defined as a reduction of POEM of greater than 4 points
Measure: Change from Baseline on the Scoring Atopic Dermatitis Index(SCORAD)
TimeFrame: Baseline and Week 2;4;8 and Month 6;12
Description: Scoring Atopic Dermatitis Index (SCORAD), which consists of objective signs (lesion area, lesion severity) and subjective symptoms as well as a visual analogue scale assessing pruritus and sleep impact.
Measure: Change from Baseline on scratching times
TimeFrame: Baseline and Week 2;4;8 and Month 6;12
Description:
Measure: Change from Baseline on the Itchy Quality of Life(ItchyQoL)
TimeFrame: Baseline and Month 6
Description: Itchy Quality of Life (Itchy QoL): assess the impact of pruritus symptoms on quality of life. The Chinese version of Itchy Quality of Life (QOL) consists of 22 items, including three dimensions of symptoms, mood and functional activities, with good reliability and validity
Measure: Change from Baseline on structural MRI (3D; DTI) and functional MRI (resting state; task state)
TimeFrame: Baseline and Month 6
Description: MRI data were acquired on a Siemens scanner using a 64-channel head coil,We used structural MRI to measure voxel-base morphometry analysis of brain regions as well as changes in DTI connectivity activity. We will compare structural and functional magnetic resonance differences between AD and healthy controls, structural magnetic resonance and functional magnetic resonance differences between AD after 6 months of ICBT therapy, AD control and baseline, and differences between AD and healthy controls after 6 months

Trial Information

NCT ID

NCT05502848

Status

Unknown

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Xiangya Hospital of Central South University

Last Updated

December 15, 2025