Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis

Moderate/Severe Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745159
• Other study ID #: ACN-PRT-AD-12-1
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2012
• Last updated: August 4, 2014
• Start date: September 2012
• Est. completion date: November 2013

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Moderate/Severe Atopic Dermatitis

Intervention

Drug:
• tacrolimus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma China, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first DE (disease exacerbation)		6 months of DCP(Disease Control Period) after 2 to 6 weeks of OLP(Open Label Period)	No
Secondary	Number of DEs during the DCP		6 months of DCP (Disease Control Period)	No
Secondary	Eczema Area and Severity Index (EASI)		6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)	No
Secondary	Investigator`s Global Assessment (IGA)		6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)	No
Secondary	Duration of DE during DCP		6 months of DCP (Disease Control Period)	No
Secondary	The overall efficacy during OLP		After 2 to 6 weeks of OLP (Open Label Period)	No
Secondary	Quantity of tacrolimus ointment used		6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)	No
Secondary	Incidence of adverse events		6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)	No

External Links

•   Link to Results on JAPIC - enter 140526 in the JapicCTI-RNo. field