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CompletedNCT00509990Updated Apr 18, 2018

Open Label Study of Long Term Treatment of Pediatric Treatment of Atopic Dermatitis With Pimecrolimus Cream 1% Within a Usual Clinical Setting

A Phase 4 interventional study of Pimecrolimus in Atopic Dermatitis, sponsored by Novartis Pharmaceuticals. Completed at 6 sites in 2 countries. Open to participants aged 3 Months to 12 Years. Per ClinicalTrials.gov, last updated 2018-04-18.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
3 Months to 12 Years
Sex
All
01

Study 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

02

Conditions studied

  • Atopic Dermatitis

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Keywords

  • Atopic dermatitis, pimecrolimus, children
03

In context

Dermatitis, Atopic

1,444 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.

This study's planned enrollment of 200 is above the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,711 studies on the registry; 218 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 435 (75%) have results posted.

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

04

Who can participate

Ages eligible
3 Months to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Investigator Global Assessment ≥ 4 (severe/very severe disease)
  • Patients with active skin viral infections (i.e, herpes simplex, herpes zoster, varicella)
  • Patients with atopic dermatitis, with active clinical infection on area of disease. All active infections must be treated prior to trial inclusion
  • 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)
  • Other protocol-defined inclusion/exclusion criteria may apply
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Interventions

06

What researchers measure

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

07

Study locations

6 sites
  • Novartis Investigative Site
    México, Mexico
  • Novartis Investigative Site
    Monterrey, Mexico
  • Novartis Investigative Site
    Puebla City, Mexico
  • Novartis Investigative Site
    Aragua, Venezuela
  • Novartis Investigative Site, Edo
    Carabobo, Venezuela
  • Novartis Investigative Site
    Caracas, Venezuela
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2005 and a primary completion of Sep 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2007
First posted
Aug 1, 2007
Start
Apr 2005
Primary completionActual
Sep 2007
Last update
Apr 18, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00509990
Responsible party
Sponsor
First posted
Aug 1, 2007
Start date
Apr 2005
Primary completion
Sep 2007
Last update
Apr 18, 2018

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 Apr 2018. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Pimecrolimus

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