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Verification Study of Ciclosporin for Atopic Dermatitis

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: October 3, 2005
Last updated: November 1, 2011
Last verified: November 2011

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 Intervention Phase
Severe Atopic Dermatitis Drug: ciclosporin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Verification Study of Ciclosporin for Atopic Dermatitis

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Study Start Date: May 2004
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00232076

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

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00232076     History of Changes
Other Study ID Numbers: COLO400D1303
Study First Received: October 3, 2005
Last Updated: November 1, 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 processed this record on September 21, 2017