Open Label Study of Long Term Treatment of Pediatric Treatment of Atopic Dermatitis With Pimecrolimus Cream 1% Within a Usual Clinical Setting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00509990
First received: July 31, 2007
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

An open-label, multicenter study, of long term management to evaluate effectiveness, tolerability and safety of pimecrolimus cream 1% in pediatric patients with mild to moderate atopic dermatitis in a daily practice


Condition Intervention Phase
Atopic Dermatitis
Drug: Pimecrolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Multicenter Study, 52 Weeks Duration, Using Pimecrolimus Cream 1% for the Long-term Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Patients Within a Usual Clinical Setting

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To evaluate the effectiveness of pimecrolimus cream 1% in the long-term management in mild to moderate atopic dermatitis in pediatric patients in a daily practice, as assessed by: • Investigator Global Assessment • Facial Investigator Global Ass

Secondary Outcome Measures:
  • • To monitor the safety of pimecrolimus cream 1% in the long-term management as assessed by Adverse Events and Serious Adverse Events collection • To evaluate quality of life of both parent and patient assessed by questionnaire. • To determine ste

Estimated Enrollment: 200
Study Start Date: April 2005
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pimecrolimus
    Pimecrolimus cream 1 %
    Other Name: Elidel
  Eligibility

Ages Eligible for Study:   3 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 3 months to 12 years old
  • Clinical diagnosis of atopic dermatitis
  • History of mild to moderate atopic dermatitis
  • Investigator Global Assessment ≥ 1 (almost clear/clear of disease)
  • Written informed consent

Exclusion Criteria:

  • Investigator Global Assessment ≥ 4 (severe/very severe disease)
  • Patients with active skin viral infections (i.e, herpes simplex, herpes zoster, varicella)
  • Patients with atopic dermatitis, with active clinical infection on area of disease. All active infections must be treated prior to trial inclusion
  • Patients in an Immunosuppressive state or with history of malignant disease
  • Patients with clinical conditions other that Atopic Dermatitis that according to the investigator may interfere with the evaluation (i.e, Psoriasis, Netherton Syndrome)
  • Other protocol-defined inclusion/exclusion criteria may apply
  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: NCT00509990

Locations
Mexico
Novartis Investigative Site
Mexico, Mexico
Novartis Investigative Site
Monterrey, Mexico
Novartis Investigative Site
Puebla, Mexico
Venezuela
Novartis Investigative Site
Aragua, Venezuela
Novartis Investigative Site, Edo
Carabobo, Venezuela
Novartis Investigative Site
Caracas, Venezuela
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Chair: Novartis Novartis Pharma AG Basel, Switzerland
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00509990     History of Changes
Other Study ID Numbers: CASM981CVE01
Study First Received: July 31, 2007
Last Updated: November 1, 2011
Health Authority: Mexico: Secretaría de Salud, Estados Unidos Mexicanos
Venezuela: Instituto Nacional de Higiene "Rafael Rangel", Ministerio de Salud, Republica Bolivariana de Venezuela

Keywords provided by Novartis:
Atopic dermatitis, pimecrolimus, children

Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014