Long-Term Study of Ciclosporin for Atopic Dermatitis - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00232063

Purpose

In patients with severe adult atopic dermatitis, the safety and efficacy of OL27-400MEPC will be assessed by repeating oral administration at a dose of 3 mg/kg/day (2-5 mg/kg/day) in 2 divided doses daily for 8-12 weeks and recovery until 52 weeks after starting treatment

Condition	Intervention	Phase
Severe Atopic Dermatitis	Drug: ciclosporin	Phase III

Drug Information available for: Cyclosporin Cyclosporine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Long-Term Study of Ciclosporin for Atopic Dermatitis

Further study details as provided by Novartis:

Study Start Date:

May 2004

Eligibility

Ages Eligible for Study:	20 Years to 64 Years
Genders Eligible for Study:	Both

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232063

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals Japan

More Information

Study ID Numbers:	COLO400D1304
Study First Received:	October 3, 2005
Last Updated:	November 22, 2005
ClinicalTrials.gov Identifier:	NCT00232063
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Atopic Dermatitis, Ciclosporin,

Study placed in the following topic categories:

Dermatitis, Atopic
Cyclosporine
Skin Diseases
Clotrimazole
Miconazole
Tioconazole
Cyclosporins

Hypersensitivity
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Therapeutic Uses
Antifungal Agents

Physiological Effects of Drugs
Enzyme Inhibitors
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009