Bayer HealthCare has announced positive results from a Phase III trial that evaluated the safety and efficacy of a foam formulation of Finacea – 15% azelaic acid.

Last we heard from Finacea Foam was results from trials in 2011 where 401 patients were trialled.

This study examined how well finacea foam performed compared to the vehicle foam, in 960 patients. Each of the patients suffered from the papule and pustules of rosacea, having between 12 and 50 lesions on their face at the commencement of the study.

Study participants used the finacea foam, or just the foam twice a day for 12 weeks.

Somewhere less than 2% of the participants didn’t complete the trial due to an adverse reaction to either the active in inactive foam (in about the same proportion).

Interestingly the active foam group had a reduction in papules and pustules of about 13 and the foam-only on average 10.2 less.

The clinician scale for effective relief of symptoms was on average 32% improvement for the finacea foam and 23.5% for the inactive foam.

Even though the active foam was statistically significantly better than the inactive foam, you can see that indeed both offered a benefit.

PRESS RELEASE July 24, 2014, 8:00 a.m. EDT

Phase III Investigational Trial of Azelaic Acid 15% Foam Meets Both Co-Primary Endpoints in Subjects with Papulopustular Rosacea

WHIPPANY, N.J., July 24, 2014 /PRNewswire-USNewswire/ — Bayer HealthCare today announced positive results from a Phase III trial that evaluated a 15% foam formulation of its compound azelaic acid (AzA) for the topical treatment of inflammatory papules and pustules of rosacea. An AzA foam formulation is a potential treatment option to complement the currently available AzA gel formulation.

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This Phase III clinical trial, examining the efficacy and safety of the investigational drug AzA 15% foam (not approved by the US Food and Drug Administration, the European Medicines Agency, or other health authorities) compared to unmedicated vehicle foam in the topical treatment of papulopustular rosacea, met both of its primary efficacy endpoints. Compared to the foam vehicle, treatment with AzA 15% foam resulted in a higher clinician-assessed treatment success rate (32.0% vs. 23.5%, p=0.001) as well as statistically significant greater reduction in the mean nominal change of inflammatory lesions (-13.0 vs. -10.2, p<0.001).

Update: Finacea Foam has been Approved:

• Finacea Foam (azelaic acid 15%) approved by the FDA

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