Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis

This study is currently recruiting participants.
Verified December 2012 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma China, Inc. )
ClinicalTrials.gov Identifier:
NCT01745159
First received: December 6, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  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 ]

Estimated Enrollment: 120
Study Start Date: September 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745159

Contacts
Contact: Clinical Development Administration Dept. clinical_info@jp.astellas.com

Locations
China
Recruiting
Beijing, China
Recruiting
Chongqing, China
Recruiting
Guangzhou, China
Recruiting
Shanghai, China
Sponsors and Collaborators
Astellas Pharma China, Inc.
Investigators
Study Director: Medical Director Astellas Pharma Inc
  More 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: December 6, 2012
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
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014