Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis

NCT ID: NCT01745159

Last Updated: 2014-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-11-30

Brief Summary

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To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months.

Detailed Description

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This study includes three periods. First a screening period of up to one week. Second an open-label treatment period of up to six weeks where all participants apply tacrolimus ointment. Third an open-label disease control period of up to six months where half of the participants apply tacrolimus ointment and the other half of the participants do not apply treatment.

Conditions

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Moderate/Severe Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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continued tacrolimus treatment

children with moderate/severe atopic dermatitis treated with tacrolimus ointment and continuing to apply tacrolimus ointment during disease control period.

Group Type EXPERIMENTAL

tacrolimus

Intervention Type DRUG

no additional treatment

children with moderate/severe atopic dermatitis treated with tacrolimus ointment and with no additional treatment during disease control period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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tacrolimus

Intervention Type DRUG

Other Intervention Names

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Protopic

Eligibility Criteria

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Inclusion Criteria

1. Diagnosed as AD according to Williams diagnostic criteria.
2. Moderate or severe atopic dermatitis according to the criteria of Rajka and Langeland
3. At least approximately 10 % of body area
4. Patient is able to reach the centre within 3 days in case of a disease exacerbation.
5. Patient's legal representative(s) has/have given written informed consent. If the patient is capable of understanding the purposes and risks of the trial, written informed consent has been obtained from the patient as well
Minimum Eligible Age

2 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma China, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Beijing, , China

Site Status

Chongqing, , China

Site Status

Guangzhou, , China

Site Status

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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ACN-PRT-AD-12-1

Identifier Type: -

Identifier Source: org_study_id

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