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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00368719
• Other study ID #: 200614402-1
• Status: Withdrawn
• Phase: Phase 4
• First received: August 24, 2006
• Last updated: April 6, 2015
• Start date: September 2007
• Est. completion date: July 2016

Study information

• Verified date: April 2015
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To assess the long-term safety of tacrolimus ointment

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The purpose of this study is to identify the long term effects of Tacrolimus in pediatric subjects		10 Years	No

External Links

•   University of California-Davis Department of Dermatology Clinical Research