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OpenTrials
Completed

NCT Number: NCT01745159

Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis

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.

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Key information

Conditions

Moderate/Severe Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed as AD according to Williams diagnostic criteria.
  • Moderate or severe atopic dermatitis according to the criteria of Rajka and Langeland
  • At least approximately 10 % of body area
  • Patient is able to reach the centre within 3 days in case of a disease exacerbation.
  • 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

Treatment and study plan

Tacrolimus

Drug

Other names: Protopic

Primary outcomes

  1. Time to first DE (disease exacerbation)

    Time frame: 6 months of DCP(Disease Control Period) after 2 to 6 weeks of OLP(Open Label Period)

Secondary outcomes

  1. Number of DEs during the DCP

    Time frame: 6 months of DCP (Disease Control Period)

  2. Eczema Area and Severity Index (EASI)

    Time frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)

  3. Investigator's Global Assessment (IGA)

    Time frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)

  4. Duration of DE during DCP

    Time frame: 6 months of DCP (Disease Control Period)

  5. The overall efficacy during OLP

    Time frame: After 2 to 6 weeks of OLP (Open Label Period)

  6. Quantity of tacrolimus ointment used

    Time frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)

  7. Incidence of adverse events

    Time frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)

Sponsors and collaborators

Lead sponsor

Astellas Pharma China, Inc.

Industry

Registry information

Official study title

Proactive Treatment With Tacrolimus Ointment in Children With Moderate/Severe Atopic Dermatitis: A Randomized, Multicenter, Open-label Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 10, 2012
Registry last updated
Aug 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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