Trials / Terminated
TerminatedNCT00475605
A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis
APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 8,071 (actual)
- Sponsor
- LEO Pharma · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were \< 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.
Detailed description
Data will be collected at enrollment and every 6 months thereafter either by interview, Internet, or physician office visit. Each subject will be followed for 10 years in this study.
Conditions
Timeline
- Start date
- 2005-05-25
- Primary completion
- 2019-01-31
- Completion
- 2019-01-31
- First posted
- 2007-05-21
- Last updated
- 2019-12-18
Locations
313 sites across 9 countries: United States, Austria, Canada, France, Germany, Ireland, Netherlands, Poland, United Kingdom
Source: ClinicalTrials.gov record NCT00475605. Inclusion in this directory is not an endorsement.