Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis

NCT01745159 | Completed Phase 4

• 1 other identifier: ACN-PRT-AD-12-1
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 4

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.

Conditions

Moderate/Severe Atopic Dermatitis

Keywords

tacrolimus; Protopic; pediatric; atopic dermatitis; China

Outcome Measures

Primary Outcomes (1)

• Time to first DE (disease exacerbation)

  6 months of DCP(Disease Control Period) after 2 to 6 weeks of OLP(Open Label Period)

Secondary Outcomes (7)

• Number of DEs during the DCP

  6 months of DCP (Disease Control Period)

• Eczema Area and Severity Index (EASI)

  6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)

• Investigator's Global Assessment (IGA)

  6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)

• Duration of DE during DCP

  6 months of DCP (Disease Control Period)

• The overall efficacy during OLP

  After 2 to 6 weeks of OLP (Open Label Period)

Study Arms (2)

continued tacrolimus treatment

EXPERIMENTAL

children with moderate/severe atopic dermatitis treated with tacrolimus ointment and continuing to apply tacrolimus ointment during disease control period.

Drug: tacrolimus

no additional treatment

NO INTERVENTION

children with moderate/severe atopic dermatitis treated with tacrolimus ointment and with no additional treatment during disease control period.

Interventions

tacrolimus DRUG

Also known as: Protopic

continued tacrolimus treatment

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma China, Inc.: lead

Study Sites (4)

Unknown Facility

Beijing, China

Location

Unknown Facility

Chongqing, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Shanghai, China

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Dermatitis, Atopic

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 10, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 5, 2014

Record last verified: 2014-08

Locations

CN (4)