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OpenTrials
Completed

NCT Number: NCT00480896

Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment

A long-term 0.03% tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis, and prevent, delay, and reduce flares.

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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

2 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patient of any ethnic group
  • Patient was at least 2-15 years old and suffered from mild to severe atopic dermatitis (Rajka/Langeland score of at least 3)

Exclusion criteria

  • Patient had a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma
  • Patient had a clinically significant skin infection on the affected (and to be treated) area

Treatment and study plan

Tacrolimus ointment

Drug

Topical application

Other names: Protopic®, FK506 ointment

Placebo Ointment

Drug

Topical application

Primary outcomes

  1. Number of exacerbations of atopic dermatitis requiring intervention.

    Time frame: 12 months

Secondary outcomes

  1. Time to first exacerbation requiring intervention; exacerbation treatment days, periods and time to first exacerbation; physician and patient assessment of affected area, treatment response; quality of life; global response.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Clinical Study on Tacrolimus Ointment Over the Long-term. "CONTROL Study - Children"

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
May 31, 2007
Registry last updated
Sep 18, 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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