Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment

Astellas

Status and phase: Completed; Phase 3

Conditions: Dermatitis, Atopic

Treatments: Drug: Placebo ointment; Drug: tacrolimus ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT00480896

FG-506-06-41

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 2 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: tacrolimus ointment

2

Placebo Comparator group

Treatment:

Drug: Placebo ointment