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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ClinicalTrials.gov Identifier: NCT00120523 |
Recruitment Status :
Completed
First Posted : July 18, 2005
Results First Posted : January 16, 2013
Last Update Posted : February 11, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atopic Dermatitis | Drug: Pimecrolimus Drug: Topical corticosteroids | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2418 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | April 2004 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | October 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Pimecrolimus
|
Drug: Pimecrolimus
Pimecrolimus cream 1 %
Other Name: Elidel |
Active Comparator: 2
Topical corticosteroids
|
Drug: Topical corticosteroids
TCS |
- Safety Assessed by Adverse Events [ Time Frame: throughout the 5-year study ]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) [ Time Frame: throughout the 5-year study ]
- Growth Velocity (Weight) [ Time Frame: throughout the 5-year study ]
- Potential Effect on the Developing Immune System [ Time Frame: throughout the 5-year study ]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.
- Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate [ Time Frame: throughout the 5-year study ]
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 [ Time Frame: throughout the 5-year study ]TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100.
- Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) [ Time Frame: throughout the 5-year study ]
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) [ Time Frame: throughout the 5-year study ]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 [ Time Frame: throughout the 5-year study ]Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.

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Ages Eligible for Study: | 3 Months to 12 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120523

Responsible Party: | MEDA Pharma GmbH & Co. KG |
ClinicalTrials.gov Identifier: | NCT00120523 |
Other Study ID Numbers: |
CASM981C2306 |
First Posted: | July 18, 2005 Key Record Dates |
Results First Posted: | January 16, 2013 |
Last Update Posted: | February 11, 2022 |
Last Verified: | April 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Atopic dermatitis, children, infants, pimecrolimus |
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Pimecrolimus Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Dermatologic Agents Immunosuppressive Agents Immunologic Factors Calcineurin Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |