Efficacy of a Novel Rosacea Treatment System: An Investigator-Blind, Randomized, Parallel-Group Study

October 2011 | Volume 10 | Issue 10 | Original Article | 1179 | Copyright © October 2011


James J. Leyden MD

KGL, Inc., Broomall, PA

table 1
Investigator evaluations
At day 28, the proportion of patients with global improvement was 90 percent with the rosacea treatment system, 60 percent with the rosacea treatment system minus the metronidazole, and 67 percent with metronidazole plus standard skin care (Figure 1). At the same timepoint, the proportion of patients with moderate global improvement (i.e., at least 25% global improvement) was 40 percent with the rosacea treatment system, 10 percent with the rosacea treatment system minus the metronidazole, and 11 percent with metronidazole plus standard skin care (Figure 1).
table 2
Between baseline and day 28, the mean erythema score declined from 2.8 to 2.4 with the rosacea treatment system and declined from 2.5 to 2.3 with the rosacea treatment system minus the metronidazole—whereas it remained unchanged at 2.3 with metronidazole plus the standard skin care regimen (Figure 2). The reduction in erythema score from baseline in the rosacea treatment system group was statistically significant at days 14 and 28 (P≤0.05).
Patient evaluation of efficacy
Between baseline and day 28, the patients' mean perception of the severity of their rosacea declined from 2.6 to 2.0 with the rosacea treatment system and declined from 2.5 to 2.2 with the rosacea treatment system minus the metronidazole—whereas it remained unchanged at 2.0 with metronidazole plus standard skin care (Figure 3). The reduction in severity score from baseline in the rosacea treatment group was statistically significant at days 14 and 28 (P≤0.05).
Patient evaluations of tolerability
At day 28, the study regimens were considered to be very effective, effective, or somewhat effective in reducing dryness in 90 percent of patients using the rosacea treatment system, 90 percent of patients using the rosacea treatment system minus the metronidazole, and 78 percent of patients using metronidazole plus standard skin care (Figure 4).