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OpenTrials
Completed

NCT Number: NCT00510003

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

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.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

pimecrolimus

Drug

Pimecrolimus cream 1 %

Other names: Elidel

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
First posted
Aug 1, 2007
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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