Assessment of Pruritus Improvement With Pimecrolimus Treatment on the Areas Affected by Mild-to-moderate AD, in Patients 2- to 11- Year-old

NCT00510003 | Completed Phase 4

• 1 other identifier: CASM981CES02
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis, children, pimecrolimus, eczema

Outcome Measures

Primary Outcomes (1)

• Change in pruritus Visual Analogic Scale (VAS) with respect to the basal score between and within treatment groups, daily evaluation.

Secondary Outcomes (1)

• • 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

Interventions

Pimecrolimus DRUG

Pimecrolimus cream 1 %

Also known as: Elidel

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Madrid, Spain

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Novartis

  Novartis Pharma AG, Basel, Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2007
• First Posted: August 1, 2007
• Study Start: December 1, 2004
• Primary Completion: January 1, 2006
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

ES (1)