Atopic Dermatitis
Conditions
Keywords
Atopic dermatitis, children, infants, pimecrolimus, bid, od
Brief summary
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.
Interventions
DRUGPimecrolimus
Pimecrolimus cream 1 % applied twice daily (b.i.d.)
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Time to first recurrence of atopic dermatitis | — |
| Eczema Area and Severity Index (EASI) and IGA assessments at several time points. | — |
Countries
Switzerland
Outcome results
None listed