CompletedPhase 1/2

Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients

United States8 participantsStarted 2008-06

Plain-language summary

The purpose of this study is to determine the clinical and immunological effects of the phosphodiesterase type 4 inhibitor, CC-10004, on skin inflammation associated with cutaneous lupus erythematosus.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of cutaneous discoid lupus by clinical and histopathological exam Exclusion Criteria: * Systemic lupus involving the internal organs * Systemic vasculitis * History of other clinically significant disease process * History of HIV, hepatitis B or C * Concurrent use of immune modulating therapy * Evidence of incompletely treated tuberculosis * Pregnant or lactating female

What they're measuring

Cutaneous LE Diseases Area and Severity Index (CLASI) Score Based on Extent of Symptoms

Timeframe: 16 Weeks

Trial details

NCT IDNCT00708916

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-08

Results submitted2014-04-11

View on ClinicalTrials.gov More Discoid Lupus Erythematosus trials