Mild to moderate Atopic Dermatitis MedDRA version: 7.0 Level: LLT Classification code 10003641
Conditions
Interventions
Trade Name: Elidel
Product Name: Elidel
Pharmaceutical Form: Cream
INN or Proposed INN: pimecrolimus
Concentration unit: % percent
Concentration type: equal
Concentration number: 1-
Pharmaceutical for
Sponsors
NOVARTIS FARMACEUTICA, S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female - Age: between 2 – 11 years - Outpatients with diagnosis atopic dermatitis using diagnostic criteria of Williams and cols. - AD affecting = 5% of Total Body Surface Area (estimated using the patient’s palm of the hand as approximately 1% TBSA) - Baseline Investigator’s Global Assessment score of 2 (mild) or 3 (moderate) - Baseline visit pruritus associated to atopic dermatitis - Patients or patient’s legal guardian who has been informed of the study procedures and has signed the informed consent form approved for the study prior to starting any study related procedures, including washout (in case that it would be necessary). 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: - Who are using a topical medication (prescription or OTC medications) for pruritus relief within 7 days of study start - Who are taking any systemic (oral/IM/IV) medication known to have a sedating side affect or known to affect pruritus such as tranquilizers, hypnotic agents, anxiolytics (including oral doxepin), tricyclic antidepressants, corticosteriods or antihistamines (sedating or non-sedating) within 1 week prior to first application of study medication. - Phototherapy (e.g., UVB, PUVA) or systemic therapy (e.g., immunosuppressants, corticosteroids, cytostatics) known or suspected to have an effect on atopic dermatitis within 1 month prior to first application of study medication. - Topical tacrolimus ointment (Protopic) or ASM981 (Pimecrolimus) cream within 4 weeks prior to first application of study medication regardless of whether the medication was given as an investigational drug. - Topical therapy (e.g. tar, topical corticosteroid) known or suspected to have a therapeutic effect on atopic dermatitis within 7 days prior to first application of study medication - Systemic antibiotics within 1 week prior to first application of study medication - Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or a history of malignant disease - Concurrent skin disease (e.g., acne) of such severity in the study area that it could interfere with the evaluation - Atopic dermatitis triggered by a known irritant/allergen that is unavoidable - Active bacterial, viral or fungal infections that require treatment with a prohibited medication - Active infection at the site(s) of treatment - Atopic dermatitis that, in the investigator’s opinion, requires systemic therapy and will not be controlled with study medication - Investigational drugs within 8 weeks prior to first application of study medication or use of other investigational drugs during the course of this study - Known hypersensitivity to any ingredient of ASM981 cream 1% (see the Investigators Brochure)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that pimecrolimus cream 1 % is superior to vehicle cream in time of improvement of pruritus, administered twice a day to both groups on the areas affected by AD, in patients between 2 – 11 years of age with mild-to-moderate AD.;Secondary Objective: - To evaluate the efficacy (IGA and EASI improvement) of Pimecrolimus cream 1 % administered b.i.d. over vehicle cream 1 %. - To evaluate the improvement of the sleep (when it is affected in the baseline) with Pimecrolimus cream 1 % treatment administered b.i.d. in regards of ASM981 vehicle cream. - To determine safety and tolerability of Pimecrolimus cream 1 % treatment. ;Primary end point(s): The primary efficacy variable is to demonstrate that the therapeutic efficacy of Pimecrolimus cream 1 % administered b.i.d. is superior to ASM981 vehicle cream administered b.i.d. evaluating the time to pruritus improvement | — |
Countries
Spain
Outcome results
None listed