Investigative study of pathogenesis/treatment of calcineurin inhibitor vs. corticosteroid confirmatory study to prior study: Pimecrolimus and Epidermal Barrier Function, Protocol No. ELBE-2005, EudraCT No.: 2004-004824-11
Conditions
Interventions
Trade Name: elidel 1 % cream
Pharmaceutical Form: Cream
INN or Proposed INN: PIMECROLIMUS
CAS Number: CASM981A2206
Other descriptive name: Elidel
Concentration unit: % percent
Concentration type: equa
Sponsors
University of Kiel, Department of Dermatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects may be included only if the following apply at the baseline visit (day 0, before first application of study medication). Patients to be included are: · Males and females of any race. · >= 18 years old. · Have atopic dermatitis as defined by Hanifin and Rajka criteria. · History of mild to moderate atopic dermatitis · At least 10 % of each upper limb affected by atopic dermatitis excluding the surface area of the hands, as these will not be treated in order to avoid cross-contamination. As reference: one hand (palm and fingers) corresponds to 10% of patient’s upper limb surface. · One specific, representative area of the disease on each upper limb with similar size and severity on both upper limbs. These will be considered the target lesions. · A target lesion score of at least 3 to 8 (on a scale of 0-12) for both right and left target lesions and not differing more than 1 score point between the right and left sides. · Must be able to suspended treatment of atopic dermatitis with other therapies for the duration of the study (3-5 weeks). · Must be informed of study procedures and have signed the informed consent form approved for the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Females: Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test. Females of childbearing potential and not practicing a medically approved method of contraception during and up to at least 4 weeks after the end of treatment. ‘Medically approved’ contraception may include implants, injectables, combined oral contraceptives, IUDs, but also abstinence at the discretion of the investigator. Other therapies/medications: · Prior phototherapy or systemic therapy known to or suspected to have an effect on atopic dermatitis within 14 days prior to first application of study medication. Patients on a low stable dose of inhaled steroids (dose known to have negligible systemic absorption) and systemic antihistamines may participate. · Topical therapy known to or suspected to have an effect on atopic dermatitis (including topical steroids, topical tacrolimus ointment or topical pimecrolimus cream) on the upper limbs within 7 days prior to first application of study medication. · Topical therapy known to or suspected to have an effect on atopic dermatitis on other areas than upper limbs if total body surface treated is higher than 20% (due to the higher risk of systemic absorption affecting the lesions of the upper limbs) within 7 days prior to first application of study medication Concurrent diseases / conditions and history of their diseases / conditions: · Patients who have signs of skin atrophy and corticoid damage on the target areas · Patients who are immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich Syndrome) · Patients who have concurrent skin disease (e.g. impetigo) on or near the study area which could interfere with study evaluations · Patients who have acute viral skin infections (e.g. herpes simplex, varicella zoster) Investigational drug / therapy use. · Patients who have used investigational drugs within 8 weeks prior to first application of study medication or intend to use other investigational drugs during the course of the study Ingredient hypersensitivity · Patients with known hypersensitivity to any ingredient of the study medication (see technical information sheet) Compliance / reliability / investigator judgment · Patients who are, in the opinion of the investigator, known to be unreliable or non-compliant with medical treatment, or are known to miss appointments (according to patient records) · Patients who have drug abuse problems, mental dysfunction or other factors limiting their ability to cooperate fully · Patients who have any other condition or prior/present treatment which, in the opinion of the investigator, will render the patient ineligible for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm that the percentage of physiological lamellar bodies in the epidermis will be higher after three weeks treatment with pimecrolimus cream 1% than after three weeks treatment with triamcinolone acetonid cream 0.1%.;Secondary Objective: 1. To investigate if 1% pimecrolimus cream leads to a reduction of pathological ultrastructural parameters of AD representing the permeability barrier of the skin after three weeks of treatment in lesional AD epidermis compared to standard steroid therapy (0.1% triamcinolone acetonide). 2. To explore the epidermal effect on proliferation rate (Ki-67 assay), differentiation (cytokeratins, involucrin, loricrin, filaggrin, and antimicrobial peptides), and stratum corneum lipid content (sebu-tape analysis) of 1% pimecrolimus cream compared to 0.1% triamcinolone acetonide cream treatment. 3. To explore the effect of 1% pimecrolimus cream induced changes in hydration and transepidermal water loss of the epidermis compared to a standard steroid (0.1% triamcinolone acetonide cream) treatment. 4. Blood samples will be screened for filaggrin mutations and results correlated with structural changes. ;Primary end point(s): The normalization of physiological lamellar bodies after three weeks of treatment with pimecrolimus cream to be determined through ultrastructual analysis will be the primary endpoint of the study. | — |
Countries
Germany
Outcome results
None listed