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OpenTrials
Completed

NCT Number: NCT00673725

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

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

Completed

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Liverpool, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Locobase® REPAIR

Drug

emollient

Primary outcomes

  1. Change in mEASI from baseline to week 3

    Time frame: 3 Weeks

Secondary outcomes

  1. Physicians Global Evaluation of Clinical Response

    Time frame: 6 Weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe B.V.

Industry

Registry information

Official study title

A Phase IV,Open Label Study of the Treatment of Children With Moderate to Severe Atopic Dermatitis (AD) Using Locobase® REPAIR as an Adjunctive to Standard Treatment

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 7, 2008
Registry last updated
Aug 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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