NCT00509990

Brief Summary

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

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

2.4 years

First QC Date

July 31, 2007

Last Update Submit

April 16, 2018

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis, pimecrolimus, children

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • • 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

Interventions

PimecrolimusDRUG

Pimecrolimus cream 1 %

Also known as: Elidel

Eligibility Criteria

Age3 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Investigator Global Assessment ≥ 4 (severe/very severe disease)
  • Patients with active skin viral infections (i.e, herpes simplex, herpes zoster, varicella)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Novartis Investigative Site

México, Mexico

Location

Novartis Investigative Site

Monterrey, Mexico

Location

Novartis Investigative Site

Puebla City, Mexico

Location

Novartis Investigative Site

Aragua, Venezuela

Location

Novartis Investigative Site, Edo

Carabobo, Venezuela

Location

Novartis Investigative Site

Caracas, Venezuela

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Novartis

    Novartis Pharma AG, Basel, Switzerland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2007

First Posted

August 1, 2007

Study Start

April 1, 2005

Primary Completion

September 1, 2007

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

VE(3)ME(3)