NCT00666159

Brief Summary

Comparison of Protopic Ointment to Elidel Cream to assess the safety and efficacy in pediatric patients with Atopic Dermatitis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
226

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2002

Shorter than P25 for phase_4

Geographic Reach
1 country

12 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
Last Updated

September 18, 2014

Status Verified

September 1, 2014

Enrollment Period

5 months

First QC Date

April 23, 2008

Last Update Submit

September 17, 2014

Conditions

Dermatitis, Atopic

Keywords

Atopic DermatitisProtopicPediatric

Outcome Measures

Primary Outcomes (1)

  • Change Eczema Area and Severity Index (EASI)

    6 Weeks

Secondary Outcomes (3)

  • Investigator's Global Atopic Dermatitis Assessment (IGADA)

    6 Weeks

  • Patient's evaluation of itch

    6 Weeks

  • Body surface area affected

    6 Weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: tacrolimus ointment

2

ACTIVE COMPARATOR
Drug: pimecrolimus cream

Interventions

tacrolimus ointmentDRUG

topical

Also known as: Protopic, FK506 ointment
1
pimecrolimus creamDRUG

topical

Also known as: Elidel
2

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of Atopic Dermatitis which is rated moderate, severe or very severe using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body's surface area
  • If female, and of childbearing potential, patient has a negative pregnancy test and agrees to practice effective birth control during the study

You may not qualify if:

  • Patient has a skin disorder other than Atopic Dermatitis in the areas to be treated
  • Patient has extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
  • Patient has clinically infected Atopic Dermatitis at baseline
  • Patient is likely to require systemic corticosteroids, or the patient is likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
  • Patient has a known hypersensitivity to macrolides or any excipient of either study medication
  • Patient has a chronic condition which is either not stable or not well controlled
  • Patient is pregnant or breast feeding an infant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

New Haven, Connecticut, 06519, United States

Location

Unknown Facility

Miami, Florida, 33136, United States

Location

Unknown Facility

Miami, Florida, 33155, United States

Location

Unknown Facility

Chicago, Illinois, 60614, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Clinton Township, Michigan, 48038, United States

Location

Unknown Facility

Omaha, Nebraska, 68144, United States

Location

Unknown Facility

Reno, Nevada, 89511, United States

Location

Unknown Facility

Chapel Hill, North Carolina, 27599, United States

Location

Unknown Facility

Wilmington, North Carolina, 28401, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27157, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • Paller AS, Lebwohl M, Fleischer AB Jr, Antaya R, Langley RG, Kirsner RS, Blum RR, Rico MJ, Jaracz E, Crowe A, Linowski GJ; US/Canada Tacrolimus Ointment Study Group. Tacrolimus ointment is more effective than pimecrolimus cream with a similar safety profile in the treatment of atopic dermatitis: results from 3 randomized, comparative studies. J Am Acad Dermatol. 2005 May;52(5):810-22. doi: 10.1016/j.jaad.2004.12.038.

    PMID: 15858471BACKGROUND

  • Kirsner RS, Heffernan MP, Antaya R. Safety and efficacy of tacrolimus ointment versus pimecrolimus cream in the treatment of patients with atopic dermatitis previously treated with corticosteroids. Acta Derm Venereol. 2010;90(1):58-64. doi: 10.2340/00015555-0748.

    PMID: 20107727BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Tacrolimuspimecrolimus

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

  • Use central contact

    Astellas Pharma US, Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 24, 2008

Study Start

December 1, 2002

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

September 18, 2014

Record last verified: 2014-09

Locations

US(12)