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CompletedNCT00510003Updated Nov 18, 2016

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

A Phase 4 interventional study of Pimecrolimus in Atopic Dermatitis, sponsored by Novartis Pharmaceuticals. Completed at 1 site in Spain. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2016-11-18.

Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
117
Allocation
Randomized
Ages
2 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Atopic dermatitis, children, pimecrolimus, eczema
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 117 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
All

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

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
117 participants (actual)

Interventions

  • DrugPimecrolimus

    Pimecrolimus cream 1 %

    Also known as: Elidel

06

What researchers measure

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

07

Study locations

1 site
  • Novartis Investigative Site
    Madrid, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00510003
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Aug 1, 2007
Start date
Dec 2004
Primary completion
Jan 2006
Last update
Nov 18, 2016

Study contacts

Novartis
study chair · Novartis Pharma AG, Basel, Switzerland
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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