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

A Multi-Center Study to Assess the Impact of Topical Corticosteroids on the Safety and Efficacy of Protopic Ointment in the Short-Term Treatment of Atopic Dermatitis and to Assess Protopic in the Long-term Management of Atopic Dermatitis

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00106496
Enrollment
410
Registered
2005-03-28
Start date
2004-10-31
Completion date
2006-07-31
Last updated
2014-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis, Atopic

Keywords

Treatment Effectiveness, Treatment Efficacy, Immunomodulator, Topical, Tacrolimus, Topical, Dermatitis, Atopic, Eczema, Atopic, Atopic Dermatitis

Brief summary

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

Detailed 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.

Interventions

DRUGProtopic

topical

DRUGCorticosteroid

topical

DRUGplacebo

topical

Sponsors

Astellas Pharma Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment2 weeks

Secondary

MeasureTime frame
Percentage of patients reporting cutaneous adverse events overallDay 4 through end of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026