Connetics dermatitis foam shows positive results in phase 3 trial

By Elaine Rigoli

Tampa, Fla., Aug. 28 - Connetics Corp. announced a positive outcome in a phase 3 clinical trial of Extina (ketoconazole) foam, 2%, formulated in VersaFoam-HF, for the treatment of seborrheic dermatitis.

The Extina clinical study was a four-week, double-blinded, active- and placebo-controlled trial that included 1,162 patients at 24 centers in the United States. The trial was designed to demonstrate that Extina is superior to placebo foam as measured by the primary endpoint of Investigator's Static Global Assessment (ISGA).

The ISGA for this trial was an overall assessment of the severity of seborrheic dermatitis with respect to the clinically relevant signs of the disease. The treatment success based on ISGA showed a 56% response for Extina and a 42% response for placebo foam, a statistically significant difference.

The trial also demonstrated non-inferiority versus an active comparator arm of ketoconazole cream.

The treatment success based on the ISGA showed a 56% response for Extina and a 56% response for the reference ketoconazole product.

"We look forward to the prospect of submitting a Class 2 Resubmission to the FDA by the end of the year and obtaining approval to market Extina in the United States six months after submission," executive vice president Lincoln Krochmal said in a news release.

Connetics, based in Palo Alto, Calif., is a specialty pharmaceutical company.

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