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

This study has been completed.

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
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




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