NCT00368719

Brief Summary

To assess the long-term safety of tacrolimus ointment

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2007

Longer than P75 for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2006

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
8.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

First QC Date

August 24, 2006

Last Update Submit

April 6, 2015

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • The purpose of this study is to identify the long term effects of Tacrolimus in pediatric subjects

    10 Years

Study Arms (1)

1

NO INTERVENTION
Drug: Tacrolimus

Interventions

TacrolimusDRUG

Participants will be followed for 10 years to study the effects of Tacrolimus.

1

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Subject has/had atopic dermatitis.
  • Subject has applied tacrolimus ointment 0.03% or 0.1% for at least 6 weeks, continuously or intermittently. This may include subjects who have been enrolled in previous tacrolimus ointment studies and/or subjects with commercial product exposure prior to study enrollment.
  • Subject age at the first tacrolimus ointment exposure is/was \<16 years of age.
  • Subject/Caregiver has given written informed consent and assent as required by state and/or governmental laws, including access to all relevant clinical and medication data, and the storage and analysis of these data.
  • Subject/Caregiver agrees to comply with the program requirements including an annual physical exam and biennial dermatological exam and agrees to be contacted and provide information as described in this document to Primary Investigator Dr. Lamb and Covance Periapproval Services, Inc.

You may not qualify if:

  • Subjects who do not have/ have not had Atopic Dermatitis.
  • Subjects must have used Tacrolimus ointment prior to age 16.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Fu-Tong Liu, M.D., Ph.D.

    Physician with UC Davis Department of Dermatology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2006

First Posted

August 25, 2006

Study Start

September 1, 2007

Study Completion

July 1, 2016

Last Updated

April 7, 2015

Record last verified: 2015-04