NCT00794274

The Efficacy and Safety of CC-10004 in Chronic Cutaneous Sarcoidosis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To determine whether CC-10004, a phosphodiesterase inhibitor, is useful in treating chronic cutaneous sarcoidosis.

Detailed description

This will be an open label, phase II trial of CC-10004 for chronic cutaneous sarcoidosis. It will include two centers (University of Cincinnati and Medical University of South Carolina). The study will evaluate patients with chronic disease who are on a stable treatment regimen and have no significant change in their Sarcoidosis Skin Activity and Severity Index score (SASI) at two visits at least one month apart.

Conditions

• Sarcoidosis
• Cutaneous Sarcoidosis

Interventions

Type	Name	Description
DRUG	CC-100004	After the screening period, subjects will receive CC-10004 20mg by mouth BID for 84 days. The 84-day duration of treatment is expected to provide adequate time to assess the short-term efficacy and safety of CC-10004 in a population of subjects with chronic cutaneous sarcoidosis.

Timeline

• Start date: 2008-11-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2008-11-20
• Last updated: 2013-04-12

Locations

1 site across 1 country: United States