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Verification Study of Ciclosporin for Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT00232076
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : November 2, 2011
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

To assess the efficacy and safety of oral OL27-400MEPC 3 mg/kg/day (2-5 mg/kg/day) in 2 divided doses daily for 8 weeks to patients with severe adult atopic dermatitis.


Condition or disease Intervention/treatment Phase
Severe Atopic Dermatitis Drug: ciclosporin Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Verification Study of Ciclosporin for Atopic Dermatitis
Study Start Date : May 2004
Primary Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Appropriate the definition/diagnosis criteria of atopic dermatitis of the Japanese Dermatological Association
  • Patients with severest atopic dermatitis [according to the "Guidelines for Treatment of Atopic Dermatitis 2002, the severity of atopic dermatitis will be classified as severest when an eruption associated with severe inflammation (a lesion associated with erythema, papule, erosion, infiltration, lichenification, etc.) is noted on at least 30% of body surface on the day of subject enrollment].

Exclusion Criteria:

  • - Patients who received oral preparations, injections, inhaled preparations and suppositories of steroids or immunosuppressants other than tacrolimus hydrate ointments within 14 days of subject enrollment
  • Patients who might receive the oral/injection drugs which are known to enhance nephrotoxicity, increase serum potassium levels, HMG-CoA reductase inhibitors or theophylline during the treatment period.
  • Patients who received or are receiving an ultraviolet therapy (PUVA therapy, etc.)
  • Patients with hypertension, active infectional disease, gout etc. Other protocol-defined exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232076

Sponsors and Collaborators
Novartis Pharmaceuticals
Study Chair: Novartis Pharmaceuticals Japan Novartis Pharmaceuticals Japan

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00232076     History of Changes
Other Study ID Numbers: COLO400D1303
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: November 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Atopic Dermatitis, Ciclosporin,

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors