Back to results5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pimecrolimus
Topical corticosteroids
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, children, infants, pimecrolimus
Eligibility Criteria
Inclusion Criteria: Aged 3 to < 12 months Diagnosis of AD fulfilling the diagnostic criteria of Seymour AD affecting at least 5% total body surface area Investigator's Global Assessment (IGA) score of 2 or 3, corresponding to mild-to-moderate disease at baseline Informed consent Exclusion Criteria: Phototherapy, systemic therapy (e.g., immunosuppressants, cytostatics), systemic corticosteroids within 4 weeks Topical tacrolimus or pimecrolimus within 2 weeks Topical therapy (e.g., tar, topical corticosteroids) within 3 days Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease Active acute viral skin infection (e.g. herpes simplex, herpes zoster, chicken pox), and/or clinically infected AD Failure to thrive (e.g., weight or height/length below the 5th percentile) or developmental abnormalities such as head circumference less than 5th and more than 95th percentile Known hypersensitivity to any ingredient of pimecrolimus cream 1% or topical corticosteroids Clinical conditions other than AD that according to investigator can interfere with the evaluation
Sites / Locations
- Phoenix Children's Hospital
- Cholla Pediatrics
- Arkansas Pediatric Clinic
- Little Rock Allergy & Asthma Clinic
- 9540 Artesia Blvd., Suite #1
- Pediatric Care Medical Group, Inc.
- Longmont Clinical Research
- Children's Skin Center
- Pediatric Research Center of South Florida
- AeroAllergy Research Laboratories of Savanah, Inc.
- The Pediatric Center
- Wayne State University Dermatology
- Michigan State University - Kalamazoo Center for Med Studies
- Respiratory Medicine Research Institute of Michigan
- SMDC Health System
- Dermatology Center for Children
- University of Minnesota - Dept. of Dermatology
- Radiant Research
- Dermatology Associates of Rochester, P.C.
- Capitol Pediatrics & Adolescent Center
- Dermatology Research Associates
- Ohio Pediatrics, Inc.
- The Portland Clinic
- Calcagno Research and Development
- Allergy & Asthma Consultants, LLP
- Allergic Disease and Asthma Center
- University of Tennessee - Dept. of Pediatrics
- Suzanne Bruce& Associates, PA
- Grand Parkway Pediatrics
- Virginia Commonwealth University
- Novartis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Pimecrolimus
Topical corticosteroids
Outcomes
Primary Outcome Measures
Safety Assessed by Adverse Events
crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period
Growth Velocity (Height)
Growth Velocity (Weight)
Potential Effect on the Developing Immune System
number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only.
Secondary Outcome Measures
Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate
IGA = Investigator's global Assessment. CI = Confidence interval for treatment success using binomial distribution: lower CI<0 is set to 0, upper CI>100 is set to 100.
Treatment success (n): IGA score of 0 or 1 (clear or almost clear). Outcome gives percentage of patients with treatment success.
Body Surface Area Involved With Atopic Dermatitis
TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100.
Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)
PIQoL-AD questionnaire (28 questions) was only done in countries where validated questionnaire was available: Germany, Hungary, Netherlands, Spain, UK and US.
For the purposes of data presentation, a "Not True" response was coded a value of zero and a "True" a value of one. The total score (i.e., sum of individual questions) was calculated; lower the score, better the QoL. Minimum score = 0; maximum score = 28. If the patient has answered ≤14 questions at a time point, then the patient's total score at the time point was set to missing.
Vital Signs and Physical Examinations: Blood Pressure (BP)
Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.
Vital Signs and Physical Examinations: Pulse
Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.
Full Information
NCT ID
NCT00120523
First Posted
July 11, 2005
Last Updated
February 4, 2022
Sponsor
MEDA Pharma GmbH & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT00120523
Brief Title
5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis
Official Title
Five-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 to Less Than 12 Months of Age With Mild to Moderate Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MEDA Pharma GmbH & Co. KG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than 12 months of age compared to topical corticosteroids (TCS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, children, infants, pimecrolimus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2418 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Pimecrolimus
Arm Title
2
Arm Type
Active Comparator
Arm Description
Topical corticosteroids
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus
Other Intervention Name(s)
Elidel
Intervention Description
Pimecrolimus cream 1 %
Intervention Type
Drug
Intervention Name(s)
Topical corticosteroids
Intervention Description
TCS
Primary Outcome Measure Information:
Title
Safety Assessed by Adverse Events
Description
crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period
Time Frame
throughout the 5-year study
Title
Growth Velocity (Height)
Time Frame
throughout the 5-year study
Title
Growth Velocity (Weight)
Time Frame
throughout the 5-year study
Title
Potential Effect on the Developing Immune System
Description
number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only.
Time Frame
throughout the 5-year study
Secondary Outcome Measure Information:
Title
Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate
Description
IGA = Investigator's global Assessment. CI = Confidence interval for treatment success using binomial distribution: lower CI<0 is set to 0, upper CI>100 is set to 100.
Treatment success (n): IGA score of 0 or 1 (clear or almost clear). Outcome gives percentage of patients with treatment success.
Time Frame
throughout the 5-year study
Title
Body Surface Area Involved With Atopic Dermatitis
Description
TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100.
Time Frame
throughout the 5-year study
Title
Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)
Description
PIQoL-AD questionnaire (28 questions) was only done in countries where validated questionnaire was available: Germany, Hungary, Netherlands, Spain, UK and US.
For the purposes of data presentation, a "Not True" response was coded a value of zero and a "True" a value of one. The total score (i.e., sum of individual questions) was calculated; lower the score, better the QoL. Minimum score = 0; maximum score = 28. If the patient has answered ≤14 questions at a time point, then the patient's total score at the time point was set to missing.
Time Frame
throughout the 5-year study
Title
Vital Signs and Physical Examinations: Blood Pressure (BP)
Description
Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.
Time Frame
throughout the 5-year study
Title
Vital Signs and Physical Examinations: Pulse
Description
Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.
Time Frame
throughout the 5-year study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 3 to < 12 months
Diagnosis of AD fulfilling the diagnostic criteria of Seymour
AD affecting at least 5% total body surface area
Investigator's Global Assessment (IGA) score of 2 or 3, corresponding to mild-to-moderate disease at baseline
Informed consent
Exclusion Criteria:
Phototherapy, systemic therapy (e.g., immunosuppressants, cytostatics), systemic corticosteroids within 4 weeks
Topical tacrolimus or pimecrolimus within 2 weeks
Topical therapy (e.g., tar, topical corticosteroids) within 3 days
Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease
Active acute viral skin infection (e.g. herpes simplex, herpes zoster, chicken pox), and/or clinically infected AD
Failure to thrive (e.g., weight or height/length below the 5th percentile) or developmental abnormalities such as head circumference less than 5th and more than 95th percentile
Known hypersensitivity to any ingredient of pimecrolimus cream 1% or topical corticosteroids
Clinical conditions other than AD that according to investigator can interfere with the evaluation
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Cholla Pediatrics
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Arkansas Pediatric Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Little Rock Allergy & Asthma Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
9540 Artesia Blvd., Suite #1
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Pediatric Care Medical Group, Inc.
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Longmont Clinical Research
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Children's Skin Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Pediatric Research Center of South Florida
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
AeroAllergy Research Laboratories of Savanah, Inc.
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
The Pediatric Center
City
Stone Mountain
State/Province
Georgia
ZIP/Postal Code
30083
Country
United States
Facility Name
Wayne State University Dermatology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Michigan State University - Kalamazoo Center for Med Studies
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
Country
United States
Facility Name
Respiratory Medicine Research Institute of Michigan
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
SMDC Health System
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Dermatology Center for Children
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University of Minnesota - Dept. of Dermatology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Radiant Research
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Dermatology Associates of Rochester, P.C.
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Capitol Pediatrics & Adolescent Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Dermatology Research Associates
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
245230
Country
United States
Facility Name
Ohio Pediatrics, Inc.
City
Huber Heights
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
The Portland Clinic
City
Beaverton
State/Province
Oregon
ZIP/Postal Code
97006
Country
United States
Facility Name
Calcagno Research and Development
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Allergy & Asthma Consultants, LLP
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Allergic Disease and Asthma Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
University of Tennessee - Dept. of Pediatrics
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Suzanne Bruce& Associates, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Grand Parkway Pediatrics
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Novartis
City
Investigative Site
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25802354
Citation
Sigurgeirsson B, Boznanski A, Todd G, Vertruyen A, Schuttelaar ML, Zhu X, Schauer U, Qaqundah P, Poulin Y, Kristjansson S, von Berg A, Nieto A, Boguniewicz M, Paller AS, Dakovic R, Ring J, Luger T. Safety and efficacy of pimecrolimus in atopic dermatitis: a 5-year randomized trial. Pediatrics. 2015 Apr;135(4):597-606. doi: 10.1542/peds.2014-1990. Epub 2015 Mar 23.
Results Reference
derived
Learn more about this trial
5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis
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