0.03% Tacrolimus ointment long-term intermittent maintain treatment of children with moderate to severe atopic dermatitis multicenter, open, randomized, controlled study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12002479

Enrollment

Unknown

Registered

2014-09-21

Start date

2012-05-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

None listed

Interventions

treatment group:0.03% Tacrolimus ointment

control group:Conventional treatment

Eligibility

Sex/Gender

All

Age

2 Years to 15 Years

Inclusion criteria

Inclusion criteria: The first stage inclusion criteria: Meet the diagnostic criteria for Williams and Rajka and Langeland criteria for patients with moderate or severe AD patients; Age 2-15 years old, male or female; When AD recurrence patient's, within 3 days to the hospital; Patient's legal representative to sign informed consent; if patients have been able to understand the purpose of the study and risk, you will need to obtain both the patient's written consent. The second stage inclusion criteria: Completed the first phase of the patients; IGA<=2 after the first stage treatment.

Exclusion criteria

Exclusion criteria: Known tacrolimus ointment allergy patients: AD skin lesions area has serious skin infections; Serious liver and kidney disease, the blood system disease, autoimmune disease, chronic severe infections, diabetes, mental illness, taking drugs, alcoholics, etc.; Malignant tumor or other may affect the correct evaluation of curative effect of serious illnesses; Local use of glucocorticoid hormone or other immunosuppressive drugs withdrawal time less than 1 week; System application of corticosteroids and other immunosuppressive drugs(ciclosporin, Leigongteng, etc.) withdrawal time less than 4 weeks; participated in other clinical studies in one month; The researchers think that should not be Inclusion for other reasons.

Design outcomes

Primary

Measure	Time frame
The first recurrence time;	—

Secondary

Measure	Time frame
The number of the second stage recurrence;The severity of the disease of the second stage recurrence;The time of durationof the second stage recurrence;Pruritus score duration of the second stage recurrence;Total tacrolimus use amount of the second stage;	—

Countries

China

Contacts

Public ContactXuejun Zhu

bjzhuxj@gmail.com+86 010 83572211

Outcome results