Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects

Condition(s) targeted: Atopic Dermatitis

Intervention: Pimecrolimus (Drug); Pimecrolimus (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharma AG, Study Chair, Affiliation: Novartis

This study is not being conducted in the United States.

To investigate the relative efficacy of pimecrolimus cream 1% applied twice daily (b. i.d.) versus once daily (o. d.) in preventing the progression to disease "relapse".

Official title: Comparison of Pimecrolimus Cream 1% Twice-Daily to Once-Daily Dosing in the Management of Atopic Dermatitis in Pediatric Subjects

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Time to relapse of atopic dermatitis (defined as the exacerbation of atopic dermatitis to the level where a topical corticosteroid or alternative therapy is required).

Investigators Global Assessment (IGA) and pruritus (itch) assessment of atopic dermatitis at time of suspected relapse

Secondary outcome:

Time to first recurrence of atopic dermatitis

Eczema Area and Severity Index (EASI) and IGA assessments at several time points.

Minimum age: 2 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion criteria - Screening/Run-In Period

- age >= 2 years through age <=17 years of age

- IGA score of 2, 3, or 4 (mild, moderate, or severe AD) affecting >5% TBSA

- outpatients

Exclusion Criteria: Screening/Run-In period

- subjects who applied topical therapy (e. g. tar, topical corticosteroids) within 2

weeks prior to Screening

- subjects who received phototherapy (e. g. UVB, PUVA, Narrow Band) within 4 weeks of

Screening

- subjects who received any systemic immunosuppressant

- subjects who received systemic steroids

- females who are pregnant or breast-feeding, or planning to become pregnant during the

study

- subjects who are immunocompromised (e. g. lymphoma, AIDS, Wiskott-Aldrich syndrome) or

have a history of malignancy (includes basal cell carcinoma, squamous cell carcinoma, melanoma)

- subjects with open skin infections (bacterial, viral or fungal) if at the application

site.

- subjects will HSV (common cold sores) are allowed to participate in the study (if not

at the application site).

- subjects who have head lice or scabies

- subjects who present with clinical conditions other than AD that may interfere with

the evaluation (e. g., generalized erythroderma, acne, Netherton's Syndrome,psoriasis)

- subjects that require systemic therapy for the treatment of atopic dermatitis

- subjects with poor or no clinical response to tacrolimus ointment (Protopic®) or

pimecrolimus cream 1%

- subjects who used any experimental or investigational drug or therapy within 6 weeks

prior to Screening

- subjects who intend to use experimental or investigational drug therapy during the

course of this study

- subjects with known hypersensitivity to pimecrolimus 1% or related drugs (see

Investigator's Brochure)

- subjects who are non-compliant with general medical treatment, or are known to miss

appointments, or don't intend to comply with the protocol for the duration of the study

- drug abuse, mental dysfunction, or other factors limiting the subject's ability to

cooperate fully with study-related procedures

- subjects known to be unreliable or may be unable to complete the study

- any condition or prior/present treatment that would render the subject ineligible for

the study

Inclusion criteria - Double-blind Maintenance treatment period

- Achieve complete remission of active disease (no signs or symptoms of AD) without

incidence of "relapse" by the end of 6-week Run-In period (may be earlier); or who achieve "disease improvement" (decrease in IGA score by 1 full point confirmed by the investigator) without incidence of relapse at the end of the 6-week Run-In period

Exclusion criteria - Double-blind Maintenance treatment period

- subjects who experienced a "relapse" during the Run-In period

- subjects who applied topical corticosteroids or any alternative or additional therapy

for the treatment of AD during the Run-In period

- subjects with active skin infections (bacterial, viral or fungal) except common cold

sores (HSV) at the application site

- subjects who failed to record study medication use (and non use) and dosing regimen

during the Run-In period

- subjects who failed to apply open label study drug twice daily until "disease

remission" or end of the 6 week Run-In period

- subjects who failed to record concomitant medications during the Run-In period

- failure to return open-label study drug (used, partially used, and unused tubes) at

the time double-blind study drug is dispensed. In order to avoid medication error, all open label study drug must be returned to the site before starting the Maintenance period

This study is not being conducted in the United States, Novartis Pharma AG, Basel, Switzerland

Starting date: September 2004
Ending date: September 2005
Last updated: April 22, 2008