Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment

Dermatitis, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480896
• Other study ID #: FG-506-06-41
• Status: Completed
• Phase: Phase 3
• First received: May 30, 2007
• Last updated: September 17, 2014
• Start date: June 2004
• Est. completion date: November 2005

Study information

• Verified date: September 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory AgencyHungary: National Institute of PharmacyItaly: The Italian Medicines AgencyNetherlands: Medicines Evaluation Board (MEB)Portugal: National Pharmacy and Medicines Institute
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• tacrolimus ointment
Topical application
• Placebo ointment
Topical application

Locations

Country	Name	City	State
Czech Republic	3 Sites	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Finland,  France,  Germany,  Hungary,  Italy,  Netherlands,  Portugal,  Spain,  United Kingdom, 

References & Publications (1)

Thaçi D, Reitamo S, Gonzalez Ensenat MA, Moss C, Boccaletti V, Cainelli T, van der Valk P, Buckova H, Sebastian M, Schuttelaar ML, Ruzicka T; European Tacrolimus Ointment Study Group. Proactive disease management with 0.03% tacrolimus ointment for children with atopic dermatitis: results of a randomized, multicentre, comparative study. Br J Dermatol. 2008 Dec;159(6):1348-56. doi: 10.1111/j.1365-2133.2008.08813.x. Epub 2008 Sep 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of exacerbations of atopic dermatitis requiring intervention.		12 months	No
Secondary	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.		12 months	No

External Links

•   Link to Results on JAPIC - enter 140604 in the JapicCTI-RNo. field