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NCT00130364 Clinical Trial

Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:
Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00130364
Other study ID # CASM981C2440
Secondary ID
Status Completed
Phase Phase 4
First received August 12, 2005
Last updated January 10, 2008
Start date August 2005
Est. completion date August 2006

Study information
Verified date January 2008
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesSouth Korea: Korea Food and Drug Administration (KFDA)Slovakia: State Institute for Drug Control
Study type Interventional

Clinical Trial Summary

This study is not being conducted in the United States of America (USA).

Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 2 Years to 11 Years
Eligibility Inclusion Criteria:

- Mild to moderate facial atopic dermatitis

- Patients intolerant of, or dependent on, topical corticosteroids

Exclusion Criteria:

- Concurrent skin diseases (infections)

- Immunocompromised

- Recently received phototherapy or systemic therapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pimecrolimus
Pimecrolimus 1 % cream
• Placebo
Pimecrolimus vehicle cream (placebo)

Locations
Country Name City State
United States This study is not being conducted in the United States Novartis Pharmaceuticals New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)
Secondary Percentage of patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score
Secondary The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score
Secondary The percentage of patients achieving a score of 0 or 1 for pruritus (absent or mild)
Secondary Time to clearance of facial IGA (score of 0 or 1)
See also
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Terminated NCT03847389 - Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis Phase 1/Phase 2
Completed NCT04090229 - A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis Phase 1
Active, not recruiting NCT05388760 - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1) Phase 2
Completed NCT05530707 - Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer N/A
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Completed NCT03441568 - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control N/A
Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2