Locobase® REPAIR Used as an Adjunctive to Standard Therapy in Children With Moderate to Severe Atopic Dermatitis

Astellas

Status and phase: Completed; Phase 4

Conditions: Dermatitis, Atopic

Treatments: Drug: Locobase® REPAIR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00673725

EudraCT #: 2006-006462-42

REP-EC-001

Details and patient eligibility

About

To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe AD

Enrollment: 49 patients

Sex: All

Ages: 18 months to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has given written informed consent (parents or guardian, child if applicable)
• Moderate to severe AD
• Continuous use of topical corticosteroid or topical calcineurin inhibitor (TCI) as active treatment of AD for more than 4 weeks prior to screening (no change in topical corticosteroid or TCI is allowed between screening and day 1)
• In the opinion of the investigator, subject is unlikely to require a significant change to his/her current treatment regimen during the study period

Exclusion criteria

• Has infected lesions
• The last assessment of any clinical study within 3 months prior to the expected date of entering into the study
• Current use of Locobase® REPAIR
• Known allergy to Locobase® REPAIR or any of its components
• Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Locobase® REPAIR