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

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

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 cream 1%	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Eczema

Drug Information available for: Pimecrolimus

U.S. FDA Resources

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 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• 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 ]

Enrollment:	41
Study Start Date:	March 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Pimecrolimus cream 1%	Drug: Pimecrolimus cream 1% Pimecrolimus cream 1% bid, as needed

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CASM981CDE20
Study First Received:	August 21, 2006
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00367393 History of Changes
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:

Anti-Inflammatory Agents
Dermatitis, Atopic
Immunologic Factors
Skin Diseases
Pimecrolimus
Eczema
Tacrolimus
Immunosuppressive Agents
Hypersensitivity
Genetic Diseases, Inborn

Analgesics, Non-Narcotic
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Atrophy
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dermatitis, Atopic
Immunologic Factors
Physiological Effects of Drugs
Tacrolimus
Hypersensitivity
Sensory System Agents
Therapeutic Uses
Skin Diseases, Eczematous
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Skin Diseases, Genetic
Dermatologic Agents

Dermatitis
Immune System Diseases
Skin Diseases
Pimecrolimus
Immunosuppressive Agents
Pharmacologic Actions
Genetic Diseases, Inborn
Analgesics, Non-Narcotic
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 06, 2009