Back to resultsReconstitution With Pimecrolimus Cream 1% of Steroid-damaged Skin in Adults With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Pimecrolimus cream 1%
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Pimecrolimus, skin atrophy, dermoscopy, atopic dermatitis, eczema
Eligibility Criteria
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
Sites / Locations
- Novartis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Pimecrolimus cream 1%
Outcomes
Primary Outcome 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
Secondary Outcome Measures
• Epidermal thickness by optical coherence tomography at selected investigational centers
Skin thickness by ultrasound at selected investigational centers
Epidermal thickness by 3mm punch biopsies (optional)
Skin metabolism by suction blisters.
Investigator's Global Assessment (IGA)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00367393
Brief Title
Reconstitution With Pimecrolimus Cream 1% of Steroid-damaged Skin in Adults With Atopic Dermatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Pimecrolimus, skin atrophy, dermoscopy, atopic dermatitis, eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Pimecrolimus cream 1%
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus cream 1%
Other Intervention Name(s)
ASM981
Intervention Description
Pimecrolimus cream 1% bid, as needed
Primary Outcome Measure Information:
Title
• 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
Secondary Outcome Measure Information:
Title
• Epidermal thickness by optical coherence tomography at selected investigational centers
Time Frame
48 weeks
Title
Skin thickness by ultrasound at selected investigational centers
Time Frame
48 weeks
Title
Epidermal thickness by 3mm punch biopsies (optional)
Time Frame
48 weeks
Title
Skin metabolism by suction blisters.
Time Frame
48 weeks
Title
Investigator's Global Assessment (IGA)
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharm
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis
City
Novartis
Country
Germany
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
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Learn more about this trial
Reconstitution With Pimecrolimus Cream 1% of Steroid-damaged Skin in Adults With Atopic Dermatitis
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