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Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma China, Inc. )
ClinicalTrials.gov Identifier:
NCT01745159
First received: December 6, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Moderate/Severe Atopic Dermatitis
Drug: tacrolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of DEs during the DCP [ Time Frame: 6 months of DCP (Disease Control Period) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Investigator`s Global Assessment (IGA) [ Time Frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period) ] [ Designated as safety issue: No ]
  • Duration of DE during DCP [ Time Frame: 6 months of DCP (Disease Control Period) ] [ Designated as safety issue: No ]
  • The overall efficacy during OLP [ Time Frame: After 2 to 6 weeks of OLP (Open Label Period) ] [ Designated as safety issue: No ]
  • Quantity of tacrolimus ointment used [ Time Frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period) ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period) ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: September 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   2 Years to 15 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma China, Inc. )
ClinicalTrials.gov Identifier: NCT01745159     History of Changes
Other Study ID Numbers: ACN-PRT-AD-12-1
Study First Received: December 6, 2012
Last Updated: August 4, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
tacrolimus
Protopic
pediatric
atopic dermatitis
China

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Tacrolimus
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014