atopic eczema MedDRA version: M15 Level: LLT Classification code 10003641
Conditions
Interventions
Product Name: Elidel 1% Creme
Pharmaceutical Form: Cream
INN or Proposed INN: Pimecrolimus
CAS Number: 137071-32-0
Current Sponsor code: ASM981
Concentration unit: % percent
Concentration type: equal
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • age 18-60 years • clinically diagnosed atopic dermatitis according to Hanifin and Rajka • local IGA (target lesions face and cubital areas): 1-3 • clinically (naked eye) evident skin atrophy due to long term topical steroid use • Dermatophot® Score (DPS) of 4-6 on at least two target areas 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: • who are in an acute major flare condition • 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 • who were treated with topical therapy [e.g. topical steroids, tar, pimecrolimus 1% cream, tacrolimus (Protopic®)] known or suspected to have an effect on AD within 7 days prior to study entry or who have received systemic corticosteroids (i.e., oral, intravenous, intraarticular, rectal) within 4 weeks prior to study entry. Patients on a stable maintenance dose of inhaled corticosteroids may participate • who present with clinical conditions other than AD that according to investigator can interfere with the Dermatophot? evaluation (e.g., generalized erythroderma such as the genetic condition Netherton’s syndrome, other skin conditions such as psoriasis) • History of malignancy of any organ system, treated or untreated whether or not there is evidence of local recurrence or metastases • Systemic immunosuppression • Clinical signs of infection in the treatment area • History of hypersensitivity to pimecrolimus 1% cream or prednicarbate 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: To investigate the reconstitution of steroid damaged skin with pimecrolimus 1% cream by the decrease of the Dermatophot® score from baseline to end of the study.;Primary end point(s): The primary endpoint is the change of the Dermatophot score between baseline and end of study.;Secondary Objective: •To investigate the reconstitution of steroid damaged skin with pimecrolimus 1% cream by measurement of epidermal thickness with optical coherence tomography at selected centers •To investigate the reconstitution of steroid damaged skin with pimecrolimus 1% cream by measurement of skin thickness with ultrasound at selected centers •To investigate the reconstitution of steroid damaged skin with pimecrolimus 1% cream by measurement epidermal thickness by 3mm punch biopsies (optional) •To investigate the reconstitution of steroid damaged skin with pimecrolimus 1% cream by measurement of skin metabolism in suction blisters: Procollagen propeptid I and III, TGFß, Glycosaminglycan, SCCE (optional) •To investigate the reconstitution of steroid damaged skin with pimecrolimus 1% cream by RT-PCR of the suction blister roof (optional) •To investigate the control of atopic eczema with pimecrolimus 1% cream with the Investigator’s Global Assessment (IGA) | — |
Countries
Germany
Outcome results
None listed