chronically relapsing atopic hand eczema MedDRA version: 8.1 Level: LLT Classification code 10003641 Term: Atopic eczema
Conditions
Interventions
Trade Name: Elidel 1% Creme
Product Name: Elidel 1% Creme
Pharmaceutical Form: Cream
INN or Proposed INN: Pimecrolimus
CAS Number: 137071-32-0
Concentration unit: % percent
Concentration type: equal
C
Sponsors
University of Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria • clinically diagnosed atopic hand eczema • minimum severity score ( local IGA-score for hand eczema) = 3 • age 18 and older • Atopic skin diathesis according to Diepgen et al (1991) (5) 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria •More than 20% body surface area (BSA) affected by atopic eczema •who have received phototherapy (e.g., UVB, PUVA) or systemic therapy (e.g., immunosuppressants, cytostatics) known or suspected to have an effect on AD within 4 weeks prior to study entry (screening visit). •who were treated with topical therapy [e.g., tar, pimecrolimus, tacrolimus (Protopic®)] known or suspected to have an effect on atopic hand eczema within 7 days prior to study entry (screening visit). Patients on a stable maintenance dose of inhaled corticosteroids may participate. Patients who have received treatment with mometasone furoate cream 0.1% for 21 days during the screening phase without reduction of the local IGA to =2 will be excluded from the study. •who have received systemic corticosteroids (i.e., oral, intravenous, intraarticular, rectal) within 4 weeks prior to study entry. •History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases •Systemic immunosuppression •Concomitant skin disease in the study area that could interfere with evaluation of atopic eczema •Clinical signs of infection in the treatment area •History of hypersensitivity to pimecrolimus or to drugs with similar chemical structures and/or to any other ingredients of the formulation •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. •Use of other investigational drugs within 30 days of enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To investigate if an Pimecrolimus (pimecrolimus) based treatment regime prolongs the time to relapse after control of a flare compared with a treatment with Pimecrolimus vehicle plus emollients in patients with chronically relapsing atopic hand eczema. ;Secondary Objective: Secondary objectives: •To determine the local IGA score (Investigator’s Global Assessment) at all visits •To determine the number of days with good/satisfactory disease control •To investigate the effect on the HECSI score (hand eczema severity score) at all visits •To demonstrate the positive effect of the pimecrolimus based treatment on the epidermal barrier recovery. ;Primary end point(s): To investigate if an Pimecrolimus based treatment regime prolongs the time to relapse after control of a flare compared with a treatment with Pimecrolimus vehicle plus emollients in patients with chronically relapsing atopic hand eczema. | — |
Countries
Germany
Outcome results
None listed