CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,418 enrolled
Drug / intervention
Pimecrolimus +1 moredrug
Likely dose
Pimecrolimus cream 1%AI-extracted
Key inclusion· 4
  • ✓Age 3 to less than 12 months
  • ✓Diagnosis of atopic dermatitis meeting Seymour diagnostic criteria
  • ✓Atopic dermatitis affecting at least 5% total body surface area
  • ✓Investigator's Global Assessment score 2 or 3 (mild to moderate disease)
Key exclusion· 8
  • ✕Phototherapy within 4 weeks
  • ✕Systemic immunosuppressants or systemic corticosteroids within 4 weeks
  • ✕Topical tacrolimus or pimecrolimus within 2 weeks
  • ✕Topical therapy (tar, topical corticosteroids) within 3 days

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00120523
NCT00120523Phase 3Completed
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Five-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 to Less Than 12 Months of Age With Mild to Moderate Atopic Dermatitis

MEDA Pharma GmbH & Co. KG·interventional·Posted Jul 18, 2005·Updated Feb 11, 2022

In Brief

A Phase 3 clinical trial evaluating Pimecrolimus and Topical corticosteroids for Atopic Dermatitis. Completed, enrolled 2,418 participants across 31 sites in 2 countries.

Detailed Summary

The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than 12 months of age compared to topical corticosteroids (TCS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesGermany, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 18, 2005
Enrollment StartApr 1, 2004
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 21.0 years ago

Interventions

Pimecrolimusdrug

Pimecrolimus cream 1 %

Topical corticosteroidsdrug

TCS