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Cytochroma finishes recruitment in psoriasis trial

Cytochroma has completed the enrollment of patients in a phase II clinical trial of its cream for chronic plaque psoriasis.

A total of 147 subjects with chronic plaque psoriasis have been enrolled and are undergoing a 12-week course of treatment with one of three different concentrations of CTA018 cream or a matching placebo. All subjects are receiving once daily topical treatment over a maximum of 15% body surface area.

The primary efficacy endpoint of the trial is the Physician Static Global Assessment, which is a commonly used psoriasis severity assessment scale required by the FDA. The primary safety endpoints of the trial include adverse events and clinical laboratory measurements. Patient perceptions of CTA018 cream are being evaluated in addition to several other secondary endpoints.

Cytochroma said the enrolment has been completed ahead of schedule and expects the results of this trial to be released in July 2007.

“Many chronic plaque psoriasis patients are not satisfied with the efficacy of current topical treatments, and even products that are effective are often discontinued over time due to side effects or treatment resistance,” said Dr Mark Lebwohl, Chairman of the Medical Board of the National Psoriasis Foundation.

CTA018 cream was previously studied in two phase I clinical trials and demonstrated to be both well tolerated and efficacious in the treatment of patients with psoriasis.