Official Title: “An Open-Label Multicenter 12-Month Long Term Study on Skin Reconstitution With Pimecrolimus Cream 1% in Adult Patients With Atopic Eczema and Corticosteroid Induced Skin Damage”

Topical steroid use may lead to skin deterioration and spider veins. This study will examine long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and its effect on skin reconstitution of steroid-damaged skin and disease control.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2007

Intervention(s) in this Clinical Trial

• Drug: Pimecrolimus cream 1%
  • Pimecrolimus cream 1% bid, as needed

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Pimecrolimus cream 1%

Primary Measures

• • Decrease of the Dermatophot (a combination of a dermatoscope and a camera) score on skin deterioration and spider veins from baseline to end of the study
  • Time Frame: 48 weeks
    Safety Issue?: No

Secondary Measures

• • Epidermal thickness by optical coherence tomography at selected investigational centers
  • Time Frame: 48 weeks
    Safety Issue?: No
• Skin thickness by ultrasound at selected investigational centers
  • Time Frame: 48 weeks
    Safety Issue?: No
• Epidermal thickness by 3mm punch biopsies (optional)
  • Time Frame: 48 weeks
    Safety Issue?: No
• Skin metabolism by suction blisters.
  • Time Frame: 48 weeks
    Safety Issue?: No
• Investigator's Global Assessment (IGA)
  • Time Frame: 48 weeks
    Safety Issue?: No

Inclusion Criteria:

• clinically diagnosed AD
• almost clear to mild AD (local IGA [target lesions face and cubital areas] score of 1-3)
• clinically (i.e. to the unaided eye) evident skin atrophy due to long-term topical steroid use
• Dermatophot Score (DPS - composed of skin atrophy and telangiectasia) of 4-6 on at least two target areas

Exclusion Criteria:

• Phototherapy or systemic therapy known or suspected to have an effect on AD within 4 weeks prior to study entry
• Topical therapy known or suspected to have an effect on AD within 7 days prior to study entry or systemic corticosteroids within 4 weeks prior to study entry
• Clinical conditions other than AD that according to investigator can interfere with the Dermatophot evaluation

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharm Study Chair Novartis  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00367393

Study ID Number: CASM981CDE20

ClinicalTrials.gov Identifier: NCT00367393

Health Authority: Germany: Federal Institute for Drugs and Medical Devices