A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis (APPLES™)

Study identification

• EU PAS number:
  EUPAS12360
• Study ID:
  36609
• Official title and acronym:
  A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis (APPLES™)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Canada

  France

  Germany

  Ireland

  Netherlands

  Poland

  United Kingdom

  United States
• Study description:
  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 the first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 314 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:03/01/2005

Actual:03/01/2005

Study start date

Planned:25/05/2005

Actual:25/05/2005

Date of interim report, if expected

Actual:26/10/2018

Date of final study report

Planned:02/01/2023

Actual:08/07/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

LEO Pharma A/S

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

ClinicalTrials.gov, registration number NCT00475605.