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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120523
• Other study ID #: CASM981C2306
• Status: Completed
• Phase: Phase 3
• Start date: April 2004
• Est. completion date: October 2010

Study information

• Verified date: April 2016
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2418
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Pimecrolimus
Pimecrolimus cream 1 %
• Topical corticosteroids
TCS

Locations

Country	Name	City	State
Germany	Novartis	Investigative Site
United States	The Portland Clinic	Beaverton	Oregon
United States	9540 Artesia Blvd., Suite #1	Bellflower	California
United States	Radiant Research	Bridgeton	Missouri
United States	Allergy & Asthma Consultants, LLP	Charleston	South Carolina
United States	Dermatology Research Associates	Cincinnati	Ohio
United States	Wayne State University Dermatology	Detroit	Michigan
United States	SMDC Health System	Duluth	Minnesota
United States	Allergic Disease and Asthma Center	Greenville	South Carolina
United States	Calcagno Research and Development	Gresham	Oregon
United States	Suzanne Bruce& Associates, PA	Houston	Texas
United States	Ohio Pediatrics, Inc.	Huber Heights	Ohio
United States	Pediatric Care Medical Group, Inc.	Huntington Beach	California
United States	Michigan State University - Kalamazoo Center for Med Studies	Kalamazoo	Michigan
United States	Arkansas Pediatric Clinic	Little Rock	Arkansas
United States	Little Rock Allergy & Asthma Clinic	Little Rock	Arkansas
United States	Longmont Clinical Research	Longmont	Colorado
United States	University of Tennessee - Dept. of Pediatrics	Memphis	Tennessee
United States	Children's Skin Center	Miami	Florida
United States	Dermatology Center for Children	Minneapolis	Minnesota
United States	University of Minnesota - Dept. of Dermatology	Minneapolis	Minnesota
United States	Pediatric Research Center of South Florida	Palm Beach Gardens	Florida
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Capitol Pediatrics & Adolescent Center	Raleigh	North Carolina
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Dermatology Associates of Rochester, P.C.	Rochester	New York
United States	AeroAllergy Research Laboratories of Savanah, Inc.	Savannah	Georgia
United States	The Pediatric Center	Stone Mountain	Georgia
United States	Grand Parkway Pediatrics	Sugar Land	Texas
United States	Cholla Pediatrics	Tucson	Arizona
United States	Respiratory Medicine Research Institute of Michigan	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
MEDA Pharma GmbH & Co. KG

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Growth Velocity (Height)		throughout the 5-year study
Primary	Growth Velocity (Weight)		throughout the 5-year study
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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