CClinicalTrials.gg
CompletedNCT00232076Updated Nov 2, 2011

Verification Study of Ciclosporin for Atopic Dermatitis

A Phase 3 interventional study of ciclosporin in Severe Atopic Dermatitis, sponsored by Novartis Pharmaceuticals. Completed. Open to participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2011-11-02.

Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
20 Years to 64 Years
Sex
All
01

Study 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.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES

02

Conditions studied

  • Severe Atopic Dermatitis

Keywords

  • Atopic Dermatitis, Ciclosporin,
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

Browse Dermatitis, Atopic studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 64 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double

Interventions

  • Drugciclosporin
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00232076
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 4, 2005
Start date
May 2004
Primary completion
Mar 2005
Last update
Nov 2, 2011

Study contacts

Novartis Pharmaceuticals Japan
study chair · Novartis Pharmaceuticals Japan
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion