Back to resultsComparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Treating Pediatric Patients With Atopic Dermatitis
Primary Purpose
Dermatitis, Atopic
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
tacrolimus ointment
pimecrolimus cream
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Atopic Dermatitis, Protopic, Pediatric
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Change Eczema Area and Severity Index (EASI)
Secondary Outcome Measures
Investigator's Global Atopic Dermatitis Assessment (IGADA)
Patient's evaluation of itch
Body surface area affected
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00666159
Brief Title
Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Treating Pediatric Patients With Atopic Dermatitis
Official Title
A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Pediatric Patients With Moderate to Severe Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of Protopic Ointment to Elidel Cream to assess the safety and efficacy in pediatric patients with Atopic Dermatitis
Detailed Description
This is a two arm, randomized, investigator blinded study to compare Protopic Ointment to Elidel Cream in treating pediatric patients with moderate to severe Atopic Dermatitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Atopic Dermatitis, Protopic, Pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
226 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
tacrolimus ointment
Other Intervention Name(s)
Protopic, FK506 ointment
Intervention Description
topical
Intervention Type
Drug
Intervention Name(s)
pimecrolimus cream
Other Intervention Name(s)
Elidel
Intervention Description
topical
Primary Outcome Measure Information:
Title
Change Eczema Area and Severity Index (EASI)
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
Investigator's Global Atopic Dermatitis Assessment (IGADA)
Time Frame
6 Weeks
Title
Patient's evaluation of itch
Time Frame
6 Weeks
Title
Body surface area affected
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use central contact
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15858471
Citation
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.
Results Reference
background
PubMed Identifier
20107727
Citation
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.
Results Reference
background
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140578 in the JapicCTI-RNo. field
Learn more about this trial
Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Treating Pediatric Patients With Atopic Dermatitis
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