Assessment of Pruritus Improvement With Pimecrolimus Treatment on the Areas Affected by Mild-to-moderate AD, in Patients 2- to 11- Year-old
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: July 31, 2007
Last updated: November 1, 2011
Last verified: November 2011
The purpose of this study is to assess the efficacy and safety of pimecrolimus cream 1% in relation to the improvement of pruritus in pediatric patients (2- to 11- year-old) with mild to moderate atopic dermatitis.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||A Multicenter, 3-week, Randomized, Double-blind, Parallel-group, Vehicle-controlled Study to Evaluate the Efficacy and Safety of Pimecrolimus Cream 1% in Pediatric Patients With Mild to Moderate Atopic Dermatitis
Primary Outcome Measures:
- Change in pruritus Visual Analogic Scale (VAS) with respect to the basal score between and within treatment groups, daily evaluation.
Secondary Outcome Measures:
- • Reduction ≥ 50% in pruritus VAS with respect to basal score (responding patients) between groups and within groups (daily evaluation). • Change in sleep quality VAS in the pimecrolimus group with respect to the basal score (daily evaluation), and
| Study Start Date:
| Primary Completion Date:
||January 2006 (Final data collection date for primary outcome measure)
Pimecrolimus cream 1 %
Other Name: Elidel
|Ages Eligible for Study:
||2 Years to 12 Years
|Genders Eligible for Study:
- Male or female.
- Age: between 2 - 12 years.
- Outpatients with diagnosis of atopic dermatitis
- Atopic dermatitis affecting ≥ 5% of Total Body Surface Area at Baseline Investigator's Global Assessment score of 2 (mild) or 3 (moderate).
- Baseline visit pruritus (itching) severity assessment score of 2 (moderate) or 3 (severe).
- Patients or patient's legal guardian who has been informed of the study procedures and has signed the informed consent form approved for the study prior to starting any study related procedures, including washout (in case that it would be necessary).
- Patients being breast-fed by women receiving systemic or prohibited medication.
- Children with known hypersensitivity to study medication.
- Children who received phototherapy or systemic therapy (immunosuppressants, cytostatics) known to affect atopic dermatitis within the previous month or topical therapy (tar, topical corticosteroids), systemic corticosteroids, systemic antibiotics or leukotriene antagonists within the previous week.
- Children who received investigational drugs within 8 weeks prior to first application of study medication.
- Children who had concurrent skin disease or active bacterial, viral or fungal infection.
- Immunocompromised children (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or children with a history of malignant disease.
Other protocol-defined inclusion/exclusion criteria may apply.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510003
|Novartis Investigative Site
|Madrid, Spain |
||Novartis Pharma AG Basel, Switzerland
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 31, 2007
||November 1, 2011
||Spain: Agencia Española de Medicamentos y Productos Sanitarios
Keywords provided by Novartis:
Atopic dermatitis, children, pimecrolimus, eczema
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 05, 2014
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents