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5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis
This study has been completed.
Sponsor:
MEDA Pharma GmbH & Co. KG
Information provided by (Responsible Party):
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00120523
First received: July 11, 2005
Last updated: April 26, 2016
Last verified: April 2016
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
| Atopic Dermatitis | Drug: Pimecrolimus Drug: Topical corticosteroids | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
atopic dermatitis
MedlinePlus related topics:
Eczema
Drug Information available for:
Pimecrolimus
U.S. FDA Resources
Further study details as provided by MEDA Pharma GmbH & Co. KG:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 2418 |
| Study Start Date: | April 2004 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Pimecrolimus
|
Drug: Pimecrolimus
Pimecrolimus cream 1 %
Other Name: Elidel
|
|
Active Comparator: 2
Topical corticosteroids
|
Drug: Topical corticosteroids
TCS
|
Eligibility| Ages Eligible for Study: | 3 Months to 12 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120523
Show 31 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120523
Show 31 Study Locations
Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | MEDA Pharma GmbH & Co. KG |
| ClinicalTrials.gov Identifier: | NCT00120523 History of Changes |
| Other Study ID Numbers: |
CASM981C2306 |
| Study First Received: | July 11, 2005 |
| Results First Received: | November 9, 2012 |
| Last Updated: | April 26, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by MEDA Pharma GmbH & Co. KG:
|
Atopic dermatitis, children, infants, pimecrolimus |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Pimecrolimus Tacrolimus 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 |
ClinicalTrials.gov processed this record on August 23, 2017