Reconstitution With Pimecrolimus Cream 1% of Steroid-Damaged Skin in Adults With Atopic Dermatitis - Tabular View

Tracking Information

First Received Date ^ICMJE

August 21, 2006

Last Updated Date

November 21, 2008

Start Date ^ICMJE

March 2006

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

• 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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

• 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

Change History

Complete list of historical versions of study NCT00367393 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

• 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)

Descriptive Information

Brief Title ^ICMJE

Reconstitution With Pimecrolimus Cream 1% of Steroid-Damaged Skin in Adults With Atopic Dermatitis

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Atopic Dermatitis

Intervention ^ICMJE

Drug: Pimecrolimus cream 1%

Study Arms / Comparison Groups

Experimental: Pimecrolimus cream 1%

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00367393

Responsible Party

External Affairs, Novartis

Study ID Numbers ^ICMJE

CASM981CDE20

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Novartis Pharm

Novartis

Information Provided By

Novartis

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP