- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05023668
China Atopic Dermatitis Registry Study
China Atopic Dermatitis Registry Study: a Chinese Registry Study in Moderate-to-severe Atopic Dermatitis Patients Not Controlled by Topical Therapy
Studieöversikt
Detaljerad beskrivning
Atopic dermatitis (AD) is a chronic recurrent inflammatory skin disease, resulting in itchy, red, and skin lesion. A survey conducted in 2014 in 39 tertiary hospitals of 15 provinces in mainland China has shown that the incidence of AD in outpatients (7.8%) has been raised in recent years.
Among topical therapy of AD, corticosteroids are first line therapy. In patients with extensive and severe dermatitis, topical therapy may be insufficient. Such patients may require the addition of either oral corticosteroid or systemic immunosuppressive therapy and even phototherapy. There is no clear recommendation treatment for each kind of patients with different severity yet and there are still huge unmet medical needs for treatment. There is not clear recommendation grade for these therapy in Chinese AD guideline and no published data to demonstrate current treatment situation in real clinical practise.
The goal of clinical registry study is to document the use and effectiveness of therapeutic interventions under real-life conditions. This study will help understand the clinical characteristics, treatment utilization, treatment patterns, as well as disease-related outcomes and cost among AD patients in China.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Jianzhong Zhang
- Telefonnummer: 010-88325472
- E-post: rmzjz@126.com
Studera Kontakt Backup
- Namn: Ping Liu
- Telefonnummer: 010-88325472
- E-post: llppliuping@126.com
Studieorter
-
-
Beijing
-
Beijing, Beijing, Kina, 100044
- Rekrytering
- Peking University People's Hospital
-
Kontakt:
- Ping Liu
- Telefonnummer: 010 88325472
- E-post: llppliuping@126.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Age≥12;
- AD according to Williams diagnosis criteria (see Appendix 1);
- Moderate to severe AD that inadequately controlled by topical therapy
- Moderate-to-severe: SCORAD score≥25; or
- Inadequately controlled by topic therapies: Determined by physicians.
Exclusion Criteria:
- No.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Chinese moderate to severe atopic dermatitis patients not controlled by topical therapy
|
Inget ingripande
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Physician evaluated effectiveness of Atopic Dermatitis therapies in real life
Tidsram: At Month 12
|
Physician-reported outcome tool, SCORAD index, will be used to evaluate the objective severity of clinical signs of Atopic Dermatitis .
|
At Month 12
|
Patient-reported disease symptoms after Atopic Dermatitis therapies in real life
Tidsram: At Month 12
|
Patient Oriented Eczema Measure (POEM) will be used to assess disease symptoms
|
At Month 12
|
Patient-reported severity of pruritus after Atopic Dermatitis therapies in real life
Tidsram: At Month 12
|
Peak Pruritus Numerical Rating Scale (NRS) will be used to assess severity of pruritus.
|
At Month 12
|
Patient-reported disease control after Atopic Dermatitis therapies in real life
Tidsram: At Month 12
|
Atopic Dermatitis Control Tool (ADCT) will be used to assess long term disease control.
|
At Month 12
|
Patient-reported quality of life after Atopic Dermatitis therapies in real life
Tidsram: At Month 12
|
Dermatology Life Quality Index (DLQI) will be used to assess quality of life, and DLQI for children (cDLQL) will be used for adolescence patients.
|
At Month 12
|
The Atopic Dermatitis related economic burden
Tidsram: At Month 12
|
Economic burden of Atopic Dermatitis will be evaluated using the cost of hospitalizations and outpatient visits associated with Atopic Dermatitis during the past one year.
|
At Month 12
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Jianzhong Zhang, Peking University People's Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SGZ-2020-12888
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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