Pimecrolimus and Epidermal Barrier Function

This is an interventional basic science trial for Atopic Dermatitis focused on measuring atopic dermatitis, barrier function, pimecrolimus Read More

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.
• be able to suspended treatment of atopic dermatitis with other therapies for the duration of the study (4-6 weeks).
• Must be informed of study procedures and have signed the informed consent form approved for the study.

Exclusion Criteria:

Females:

• Who are pregnant or breastfeeding.
• Who are menstruating, capable of becoming pregnant and not practicing a medically approved method of contraception. "Medically approved" contraceptive may, at the discretion of the investigator, include abstinence. (If patients are on oral contraceptives, they must have begun treatment at least one month prior to baseline and continue at least four weeks after the last treatment).

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 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 drug abuse problems, mental dysfunction or other factors limiting their ability to cooperate fully
• Patients who any other condition or prior/present treatment which, in the opinion of the investigator, will render the patient ineligible for the study