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NCT00150059 Clinical Trial

Efficacy and Safety of Pimecrolimus Cream 1% in Patients ≥ 3 Months of Age With Mild or Moderate Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00150059
Other study ID # CASM981CPH01
Secondary ID
Status Completed
Phase Phase 4
First received September 7, 2005
Last updated February 14, 2008
Start date December 2004
Est. completion date December 2005

Study information
Verified date February 2008
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Philippines: Bureau of Food and Drugs
Study type Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of pimecrolimus cream 1% in its registered indication (treatment of patients > 3 months of age with mild to moderate atopic dermatitis)

This study is not enrolling patients in the United States.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 3 Months and older
Eligibility The patient population must consist of male or female outpatients, age =3 months old with mild to moderate atopic dermatitis (IGA = 1). Exclusion criteria are pregnancy, having active viral infections at the site(s) of treatment, presenting with systemic malignancy or active lymphoproliferative diseases/disorders, receiving phototherapy or immunosuppressive therapy, having used tacrolimus ointment and known allergy or hypersensitivity.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pimecrolimus Cream 1%

Locations
Country Name City State
Philippines This study is not being conducted in the United States Investigative Site

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Philippines, 

Outcome
Type Measure Description Time frame Safety issue
Primary Investigator Global Assessment (IGA) score for the whole body and for the face only.
Primary Pruritus (itch) severity assessments, and patient's self-assessment of disease control at the start of study and on day 7, 30 and 90 after treatment initiation.
Primary Safety assessed by adverse events.
See also
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