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

Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atopic Dermatitis

Intervention: Pimecrolimus (Drug); Corticosteroid (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis Pharmaceuticals

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.

Clinical Details

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

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

Primary outcome:

Atopic Dermatitis (AD) Disease Control Over 36 Months

Effect of Early Use of Pimecrolimus Cream 1% in Reducing the Incidence of Asthma at 6 Years of Age

Secondary outcome:

Long Term Safety in Infants and Young Children

Incidence of Allergic Rhinitis, Allergic Conjunctivitis and Food Allergies

Corticosteroid and Pimecrolimus Drug Use

Atopic Dermatitis (AD) Remission Time

Patient/Caregiver Quality of Life

Eligibility

Minimum age: 3 Months. Maximum age: 18 Months. Gender(s): Both.

Criteria:

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

Locations and Contacts

Alabama Allergy and Asthma Center, Birmingham, Alabama 35209, United States

Northwest Arkansas Pediatric Clinic, P.A., Fayetteville, Arkansas 72703, United States

The Children's Clinic of Jonesboro, Jonesboro, Arkansas 72401, United States

Southern California Research, Mission Viejo, California 92691, United States

Children's Hospital of Orange County, Orange, California 92868, United States

Stanford Dermatology Clinic and Clinical Trials Dept, Redwood City, California 94063, United States

Capital Allergy Respiratory Disease Center, Sacramento, California 95819, United States

Children's Hospital San Diego, San Diego, California 92123, United States

Allergy and Asthma Medical Group of Diablo Valley, Inc./ Clinical Research Division, Walnut Creek, California 94598, United States

National Jewish Medical and Research Center, Denver, Colorado 80206, United States

Dermatology Associates and Research, Coral Gables, Florida 33134, United States

Emerald Coast Clinical Research, Pensacola, Florida 32503, United States

Children's Memorial Hospital, Chicago, Illinois 60614, United States

Indiana University Outpatient Clinical Research, Indianapolis, Indiana 46202, United States

Central Kentucky Research Associates, Lexington, Kentucky 40509, United States

Dermatology Specialists, Louisville, Kentucky 40202, United States

Rx R & D, Metarie, Louisiana 70002, United States

Johns Hopkins Hospital, Baltimore, Maryland 21287, United States

Children's Hospital - Boston, Boston, Massachusetts 02115, United States

Dermatology, PLLC, Ann Arbor, Michigan 48103, United States

Mayo Clinic Rochester, Rochester, Minnesota 55905, United States

Central Dermatology, St Louis, Missouri 63117, United States

Skin Specialists, P.C., Omaha, Nebraska 68144, United States

Dartmouth-Hitchcock Medical Center/Dermatology Section, Lebanon, New Hampshire 03756, United States

Children's Medical Group, Hopewell Junction, New York 12533, United States

Dermatology Associates of St. Luke's - Roosevelt, New York, New York 10025, United States

Calcagno Research and Development, Gresham, Oregon 97030, United States

Oregon Health Science University - Dermatology Dept., Portland, Oregon 97201, United States

The Childrens' Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States

Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States

Tennessee Clinical Research Center, Nashville, Tennessee 37215, United States

Texas Children's Hospital, BCM, Houston, Texas 77030, United States

Alpine Medical Group, LLC, Salt Lake City, Utah 84102, United States

Granger Medical Clinic, West Valley City, Utah 84120, United States

Virginia Clinical Research, Norfolk, Virginia 23507, United States

Asthma Inc, Seattle, Washington 98105, United States

Additional Information

Starting date: October 2003
Last updated: February 25, 2011

Page last updated: August 20, 2015

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