Trials / Completed
CompletedNCT00120523
5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis
Five-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 to Less Than 12 Months of Age With Mild to Moderate Atopic Dermatitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,418 (actual)
- Sponsor
- MEDA Pharma GmbH & Co. KG · Industry
- Sex
- All
- Age
- 3 Months – 12 Months
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pimecrolimus | Pimecrolimus cream 1 % |
| DRUG | Topical corticosteroids | TCS |
Timeline
- Start date
- 2004-04-01
- Primary completion
- 2010-10-01
- Completion
- 2010-10-01
- First posted
- 2005-07-18
- Last updated
- 2022-02-11
- Results posted
- 2013-01-16
Locations
31 sites across 2 countries: United States, Germany
Source: ClinicalTrials.gov record NCT00120523. Inclusion in this directory is not an endorsement.