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

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Growth Velocity (Weight) [ Time Frame: throughout the 5-year study ] [ Designated as safety issue: Yes ]
Potential Effect on the Developing Immune System [ Time Frame: throughout the 5-year study ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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)
Genders Eligible for Study:	Both
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

Sponsors and Collaborators

MEDA Pharma GmbH & Co. KG

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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
Health Authority:	United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Belgium: Federal Agency for Medicines and Health Products, FAMHP Canada: Health Canada Chile: Instituto de Salud Pública de Chile China: Food and Drug Administration Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines Hong Kong: Department of Health Netherlands: Medicines Evaluation Board (MEB) Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Portugal: National Pharmacy and Medicines Institute Poland: Ministry of Health Russia: Pharmacological Committee, Ministry of Health Singapore: Health Sciences Authority South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Taiwan: Department of Health Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency
Individual Participant Data
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 September 27, 2016