Reconstitution With Pimecrolimus Cream 1% of Steroid-damaged Skin in Adults With Atopic Dermatitis
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
1 other identifier
interventional
41
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 21, 2006
CompletedFirst Posted
Study publicly available on registry
August 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFebruary 24, 2017
February 1, 2017
1.8 years
August 21, 2006
February 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
• 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
48 weeks
Secondary Outcomes (5)
• Epidermal thickness by optical coherence tomography at selected investigational centers
48 weeks
Skin thickness by ultrasound at selected investigational centers
48 weeks
Epidermal thickness by 3mm punch biopsies (optional)
48 weeks
Skin metabolism by suction blisters.
48 weeks
Investigator's Global Assessment (IGA)
48 weeks
Study Arms (1)
1
EXPERIMENTALPimecrolimus cream 1%
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Novartis
Novartis, Germany
Related Publications (1)
Reference: Thaci D et al TBD. CORTICOSTEROID-INDUCED SKIN DAMAGE IMPROVED WITH PIMECROLIMUS CREAM 1% TREATMENT: A 1-YEAR STUDY IN ADULTS WITH ATOPIC ECZEMA. European Academy of Dermatology and Venereology - 17th Congress. 2008; www.eadv.org
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis Pharm
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 21, 2006
First Posted
August 22, 2006
Study Start
March 1, 2006
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
February 24, 2017
Record last verified: 2017-02