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

Purpose

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.

Condition	Intervention	Phase
Atopic Dermatitis	Drug: Pimecrolimus	Phase IV

MedlinePlus related topics:

Eczema

ChemIDplus related topics:

Corticosteroids Pimecrolimus

U.S. FDA Resources

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

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

Further study details as provided by Novartis:

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)

Estimated Enrollment:	40
Study Start Date:	March 2006
Study Completion Date:	December 2007

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367393

Locations


Germany
	Novartis
	Novartis, Germany

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis Pharm	Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CASM981CDE20
First Received:	August 21, 2006
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00367393
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Pimecrolimus, skin atrophy, dermoscopy, atopic dermatitis, eczema

Study placed in the following topic categories:

Hypersensitivity

Dermatitis, Atopic

Genetic Diseases, Inborn

Skin Diseases

Hypersensitivity, Immediate

Skin Diseases, Eczematous

Pimecrolimus

Atrophy

Eczema

Skin Diseases, Genetic

Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Immunologic Factors

Immune System Diseases

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00367393