Pimecrolimus and Epidermal Barrier Function: Role for pimecrolimus in restoring skin barrier function and normalizing epidermal lipid content and differentiation in atopic epidermis: a randomized, intra-patient, double-blind (right/left arm) study in adults with atopic dermatitis treated with 1% pimecrolimus cream and 0.1% triamcinolone acetonide cream as treatment control twice daily for 3 weeks - Pimecrolimus and Epidermal Barrier Functio

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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