5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis

Study Overview
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Brief Summary
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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).

Official Title
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Five-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 to Less Than 12 Months of Age With Mild to Moderate Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Pimecrolimus
* Drug: Topical corticosteroids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Pimecrolimus | Drug: Pimecrolimus<br>* Pimecrolimus cream 1 %<br>* Other names: Elidel;|
| Active Comparator: 2<br>Topical corticosteroids | Drug: Topical corticosteroids<br>* TCS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | throughout the 5-year study | 
| Growth Velocity (Height) |  | throughout the 5-year study | 
| Growth Velocity (Weight) |  | throughout the 5-year study | 
| 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. | throughout the 5-year study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | throughout the 5-year study | 
| Body Surface Area Involved With Atopic Dermatitis | TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100. | throughout the 5-year study | 
| 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. | throughout the 5-year study | 
| 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. | throughout the 5-year study | 
| 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. | throughout the 5-year study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic dermatitis, children, infants, pimecrolimus