Clinical Efficacy of Pimecrolimus Cream in Seborrheic Dermatitis. Efficacy of pimecrolimus in normalizing clinical symptoms, explorative study of barrier function, hydration, lipid content and differentiation in seborrheic dermatitis: a randomized, double-blind study in adults with seborrheic dermatitis treated with 1 % pimecrolimus cream versus 2 % ketoconazole cream as control. - Pimecrolimus vs. Ketoconazole

• Conditions: Efficacy of pimecrolimus in normalizing clinical symptoms, explorative study of barrier function, hydration, lipid content and differentiation in seborrheic dermatitis

• Registration Number: EUCTR2005-006208-21-DE
• Lead Sponsor: Department of Dermatology, University of Kiel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

·Males and females of any race.
· >= 18 years old.
·Have mild to severe seborrheic dermatitis as defined by clinical criteria. At least 50 % of the subjects must meet the criteria for moderate or severe seborrheic dermatitis (F-IGA 2 and 3) and at least 5 subjects of each group must show lesions on the trunk.
·At least 10 % of the face must be affected by seborrheic dermatitis, excluding the surface area of the scalp, as this area is inappropriate for treatment with cream preparations.
·One specific, representative area of the disease on the face will serve as area for F-IGA scoring. This will be considered the target lesion.
·To be able to suspend treatment of seborrheic 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.

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:
·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 seborrheic eczema 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 seborrheic dermatitis (including topical steroids, topical tacrolimus ointment or topical pimecrolimus cream) on the face or trunk lesions 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, atopic dermatitis, ) 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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified