Long-term Study of Ciclosporin for Atopic Dermatitis

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

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Key information

Conditions

Severe Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ciclosporin

Drug

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start: 2004
Primary completion: 2005
First posted: Oct 4, 2005
Registry last updated: Nov 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed