Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis
This study is currently recruiting participants.
Verified December 2012 by Astellas Pharma Inc
Sponsor:
Astellas Pharma China, Inc.
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
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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:
- 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
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 June 18, 2013