Minocycline gel improves inflammatory lesion count in papulopustular rosacea

Among patients with moderate to severe papulopustular rosacea, a 1% minocycline gel showed a statistically significant mean change in the number of facial inflammatory lesions and an improvement on the Investigator’s Global Assessment scale of two grades in 12 weeks.

Adults with moderate to severe papulopustular rosacea were enrolled across 11 sites in the U.S. that compared once-daily application of BPX-04 (BioPharmX), a 1% minocycline gel vs. a vehicle control, according to a press release from the company.

Of 206 enrolled adults, the mean inflammatory lesion count was 23.9 at baseline in the vehicle treatment group and 24 in the BPX-04 group.

At baseline in the BPX-04 group, 92.7% of 96 adults had an Investigator’s Global Assessment (IGA) score of 3 (moderate) and 7.3% had an IGA score of 4 (severe). In the vehicle treatment group, 91.1% of 101 adults had an IGA score of 3 and 8.9% had a score of 4.

BioPharmX reported that BPX-04 met the primary and secondary endpoints with a statistically significant reduction in the number of facial inflammatory lesions at all time points of weeks 4, 8 and 12.

The mean change in the number of facial inflammatory lesions from baseline to week 12 was –13.6 in the BPX-04 group and –10.3 in the vehicle group (P = .004).

The proportion of adults with a two-grade improvement in IGA to 0 (clear) or 1 (almost clear) was 52.3% in the BPX-04 group and 32.3% in the vehicle group (P = .018).

The most commonly adverse events reported in both treatment groups were upper respiratory infection (5.3%), gastroenteritis (2.4%) and headache (2.4%). None were serious in nature.