Back to resultsA Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis
Primary Purpose
Dermatitis, Atopic
Status
Completed
Phase
Phase 4
Locations
International
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, Elidel
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Atopic Dermatitis rated at least mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area
- Negative pregnancy test and agrees to practice effective birth control during the study
Exclusion Criteria:
- Skin disorder other than Atopic Dermatitis in the areas to be treated
- Extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
- Clinically infected Atopic Dermatitis at baseline
- Likely to require systemic corticosteroids; or likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
- Known hypersensitivity to macrolides or any excipient of either study medication
- Chronic condition which is either not stable or not well controlled
- 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 in 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
NCT00666302
Brief Title
A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis
Official Title
A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Patients With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
November 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
A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with 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, Elidel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
413 (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 in 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
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Atopic Dermatitis rated at least mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area
Negative pregnancy test and agrees to practice effective birth control during the study
Exclusion Criteria:
Skin disorder other than Atopic Dermatitis in the areas to be treated
Extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
Clinically infected Atopic Dermatitis at baseline
Likely to require systemic corticosteroids; or likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
Known hypersensitivity to macrolides or any excipient of either study medication
Chronic condition which is either not stable or not well controlled
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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1Z4
Country
Canada
12. IPD Sharing Statement
Citations:
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
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
17538803
Citation
Fleischer AB Jr, Abramovits W, Breneman D, Jaracz E; US/Canada tacrolimus ointment study group. Tacrolimus ointment is more effective than pimecrolimus cream in adult patients with moderate to very severe atopic dermatitis. J Dermatolog Treat. 2007;18(3):151-7. doi: 10.1080/09546630701287332.
Results Reference
background
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140577 in the JapicCTI-RNo. field
Learn more about this trial
A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis
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