Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification

Atopic Dermatitis Clinical Trial

Official title:

An Investigation of the Safety and Efficacy of Elidel® 1% Cream in Atopic Disease Modification, Assessed in a 3-year Randomized Double-blind Vehicle Controlled Phase to Evaluate Effects on Atopic Dermatitis in Infants, and a 2-3 Year Open-label Phase to Evaluate the Effect of Early Intervention Versus Delayed Intervention With Elidel® on the Incidence of Asthma in Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00124709
• Other study ID #: CASM981CUS09
• Status: Terminated
• Phase: Phase 4
• First received: July 26, 2005
• Last updated: February 25, 2011
• Start date: October 2003
• Est. completion date: November 2008

Study information

• Verified date: February 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1091
• Est. completion date: November 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 18 Months

Eligibility

Inclusion Criteria:

• Diagnosis of atopic dermatitis

• Family history of atopy

• 3 to 18 months of age at baseline

• At least mild atopic dermatitis at baseline (investigator global assessment [IGA] greater or equal to 2)

• Clinical evidence of atopic dermatitis for no longer than 3 months

Exclusion Criteria:

• Diagnosis of or substantial clinical evidence for food or other allergies at baseline

Other protocol related criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Pimecrolimus
Pimecrolimus cream 1 %
• Corticosteroid
conventional corticosteroid-based treatment

Locations

Country	Name	City	State
United States	Dermatology, PLLC	Ann Arbor	Michigan
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Alabama Allergy and Asthma Center	Birmingham	Alabama
United States	Children's Hospital - Boston	Boston	Massachusetts
United States	Children's Memorial Hospital	Chicago	Illinois
United States	Dermatology Associates and Research	Coral Gables	Florida
United States	National Jewish Medical and Research Center	Denver	Colorado
United States	Northwest Arkansas Pediatric Clinic, P.A.	Fayetteville	Arkansas
United States	Calcagno Research and Development	Gresham	Oregon
United States	Children's Medical Group	Hopewell Junction	New York
United States	Texas Children's Hospital, BCM	Houston	Texas
United States	Indiana University Outpatient Clinical Research	Indianapolis	Indiana
United States	The Children's Clinic of Jonesboro	Jonesboro	Arkansas
United States	Dartmouth-Hitchcock Medical Center/Dermatology Section	Lebanon	New Hampshire
United States	Central Kentucky Research Associates	Lexington	Kentucky
United States	Dermatology Specialists	Louisville	Kentucky
United States	Rx R & D	Metarie	Louisiana
United States	Southern California Research	Mission Viejo	California
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Dermatology Associates of St. Luke's - Roosevelt	New York	New York
United States	Virginia Clinical Research	Norfolk	Virginia
United States	Skin Specialists, P.C.	Omaha	Nebraska
United States	Children's Hospital of Orange County	Orange	California
United States	Emerald Coast Clinical Research	Pensacola	Florida
United States	The Childrens' Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Oregon Health Science University - Dermatology Dept.	Portland	Oregon
United States	Stanford Dermatology Clinic and Clinical Trials Dept	Redwood City	California
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Capital Allergy Respiratory Disease Center	Sacramento	California
United States	Alpine Medical Group, LLC	Salt Lake City	Utah
United States	Children's Hospital San Diego	San Diego	California
United States	Asthma Inc	Seattle	Washington
United States	Central Dermatology	St Louis	Missouri
United States	Allergy and Asthma Medical Group of Diablo Valley, Inc./ Clinical Research Division	Walnut Creek	California
United States	Granger Medical Clinic	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atopic Dermatitis (AD) Disease Control Over 36 Months	Proportion of disease-free days in Step 2 or less (per Patient) using total number of days in study as the denominator- double-blind phase. Intent to Treat Population: defined as all randomized patients who were dispensed study medication and had at least one post baseline efficacy measurement.	36 months	No
Primary	Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age	Note: The results for this efficacy variable are not reported due to early termination of the study.	6 years	No
Secondary	Long Term Safety in Infants and Young Children	Note: The results of this secondary outcome is not reported due to early termination of the study.	6 years	Yes
Secondary	Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies	Percentage of Patients who had allergic rhinitis, allergic conjunctivitis and food allergies at the end of the 36 month double blind study.; Note: The results at six years are not reported due to early termination of the study.	6 years (36 month Double-Blind Phase)	No
Secondary	Corticosteroid and Pimecrolimus Drug Use	Corticosteroid and pimecrolimus study medication days of exposure during the 36 month double-blind phase.; Note: Although the double-blind phase was designed to be 36 months (3 years) in length, the last double-blind visit for some patients occurred after 36 months.	48 months	No
Secondary	Atopic Dermatitis (AD) Remission Time	Longest duration of atopic dermatitis (AD) remission during the 36 month double-blind treatment phase. A remission day was defined as a diary day with a positive response ("yes") to the question "No or almost no eczema?" and a response of no treatment except emollients to the question "Medication used".	36 month Double-Blind Phase	No
Secondary	Patient/Caregiver Quality of Life	Change from Baseline in the total Parents' Index of Quality of Life-Atopic Dermatitis (PIQoL-AD) score in the double-blind phase. PIQoL-AD Score = (sum of valid items/number of valid items) * 28. Scores range from a minimum value of 0 to a maximum value of 28 with a high total overall score indicating poor quality of life.	From Baseline to Visit 5 , 6, 8, 10, 12, and 14	No