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Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT01745159
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : August 5, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma China, Inc. )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Moderate/Severe Atopic Dermatitis Drug: tacrolimus Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proactive Treatment With Tacrolimus Ointment in Children With Moderate/Severe Atopic Dermatitis: A Randomized, Multicenter, Open-label Study
Study Start Date : September 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: continued tacrolimus treatment
children with moderate/severe atopic dermatitis treated with tacrolimus ointment and continuing to apply tacrolimus ointment during disease control period.
Drug: tacrolimus
Other Name: Protopic
No Intervention: no additional treatment
children with moderate/severe atopic dermatitis treated with tacrolimus ointment and with no additional treatment during disease control period.



Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745159


Locations
China
Beijing, China
Chongqing, China
Guangzhou, China
Shanghai, China
Sponsors and Collaborators
Astellas Pharma China, Inc.
Investigators
Study Director: Medical Director Astellas Pharma Inc

Additional Information:
Responsible Party: Astellas Pharma China, Inc.
ClinicalTrials.gov Identifier: NCT01745159     History of Changes
Other Study ID Numbers: ACN-PRT-AD-12-1
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: August 2014

Keywords provided by Astellas Pharma Inc ( Astellas Pharma China, Inc. ):
tacrolimus
Protopic
pediatric
atopic dermatitis
China

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action