A 22-week randomized, multicenter, parallel-group, double-blind study to compare a pimecrolimus 1% (Elidel) twice daily (B.I.D.) maintenance dosing regimen to a once daily (O.D.) maintenance dosing regimen in the management of atopic dermatitis in pediatric subjects - C2314

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 262

Inclusion 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
(estimated using the subject’s palm of the hand as approximately 1% TBSA)
• outpatients
• subject (or primary caregiver) has been informed of the study procedures and
requirements and has signed the approved informed consent form (and patient assent form if applicable)

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.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria - Screening/Run-In period
• subjects who applied topical therapy (e.g. tar, topical corticosteroids, pimecrolimus
(Elidel®) or tacrolimus (Protopic®) 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 (e.g. Neoral®,
Cyclosporine®, Prograf®, methotrexate, etc.) within 4 weeks of Screening
• subjects who received systemic steroids (e.g. oral, intravenous, intra-articular, rectal) for any reason within 4 weeks of Screening
• females who are pregnant or breast-feeding, or planning to become pregnant during the study
• females who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception (required during study and up to 4 weeks post-treatment). A medically approved” method of contraception may include abstinence at the discretion of the investigator. (A negative urine pregnancy test is required for all females of childbearing potential at Screening)
• 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

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 (whichever occurred first)
• 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 i

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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