Evaluation to Assess the Long Term Safety of Tacrolimus Ointment for Atopic Dermatitis

APPLES: A Prospective Pediatric Longitudinal Evaluation To Assess The Long Term Safety Of Tacrolimus Ointment For The Treatment Of Atopic Dermatitis

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00368719

Enrollment

Registered

2006-08-25

Start date

2007-09-30

Completion date

2016-07-31

Last updated

2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

To assess the long-term safety of tacrolimus ointment

Detailed description

To assess the long-term safety of tacrolimus ointment 0.03% or 0.1% in the treatment of subjects with atopic dermatitis under actual use conditions, including the risk of developing cutaneous or systemic malignancies. The FDA and EMEA approved Tacrolimus ointment, 0.03% in children and 0.1% and 0.03% in adults, for the treatment of atopic dermatitis. As part of the approval process, the FDA and EMEA requested a post-marketing commitment regarding the safety of long-term use of Tacrolimus ointment in pediatric atopic dermatitis subjects.

Interventions

DRUGTacrolimus

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 16 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The purpose of this study is to identify the long term effects of Tacrolimus in pediatric subjects	10 Years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026