An uncontrolled, multicenter 12 month long term study on skin reconstitution with Elidel® (pimecrolimus) 1% cream in adult patients with atopic eczema and corticosteroid induced skin damage - REPIDE

• Conditions: atopic eczema; MedDRA version: M15Level: LLTClassification code 10003641

• Registration Number: EUCTR2005-004259-37-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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

•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

Study & Design

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