A Multi-Center Study of Short and Long-term Use of Protopic Ointment in Patients With Atopic Dermatitis

Astellas

Status and phase: Completed; Phase 4

Conditions: Dermatitis, Atopic

Treatments: Drug: Corticosteroid; Drug: Protopic; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00106496

20-04-002

Details and patient eligibility

About

The purpose of the study is to determine the impact of topical corticosteroids on the safety and effectiveness of Protopic Ointment in the short-term treatment of moderate to severe Atopic Dermatitis and to compare the safety and effectiveness of Protopic Ointment to placebo in the long-term management of Atopic Dermatitis

Full description

Study includes an interim short-term, open label period. Patients could also receive a second course of open label treatment dependent on disease exacerbation.

Enrollment: 410 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient must have Atopic Dermatitis
• Patient must be at least 2 years of age

Exclusion criteria

• Patient is pregnant or breast feeding an infant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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410 participants in 6 patient groups, including a placebo group

1A

Experimental group

Treatment:

Drug: Protopic

1B

Active Comparator group

Treatment:

Drug: Corticosteroid

2

Experimental group

Description:

Open label

Treatment:

Drug: Protopic

3A

Experimental group

Treatment:

Drug: Protopic

3B

Placebo Comparator group

Treatment:

Drug: placebo

4

Experimental group

Description:

Open label

Treatment:

Drug: Protopic