Long-term Study of Ciclosporin for Atopic Dermatitis

NCT00232063 | Completed Phase 3

• 1 other identifier: COLO400D1304
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Severe Atopic Dermatitis

Keywords

Atopic Dermatitis, Ciclosporin,

Interventions

ciclosporin DRUG

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Novartis Pharmaceuticals Japan

  Novartis Pharmaceuticals Japan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 4, 2005
• Study Start: May 1, 2004
• Primary Completion: November 1, 2005
• Last Updated: November 2, 2011

Record last verified: 2011-11