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

At day 28, the proportion of patients agreeing or completely agreeing that their skin felt comfortable immediately after applying the study products was 70 percent with the rosacea treatment system, 70 percent with the rosacea treatment system minus the metronidazole, and 56 percent with metronidazole plus standard skin care (Figure 5).

Also at day 28, the proportion of patients who reported their skin was easily irritated at least sometimes was 40 percent with the rosacea treatment system, 70 percent with the rosacea treatment system minus the metronidazole, and 89 percent with metronidazole plus the standard skin care regimen (Figure 6).

Two adverse events were reported, both in the metronidazole plus standard skin care group—mild dryness on the chin in one patient and a mild burning sensation in another patient.

Patient satisfaction
Patients reported the following levels of satisfaction with their rosacea treatment at day 28: 50 percent of the rosacea treatment group were very satisfied (with 70% being satisfied or very satisfied); 30 percent of the rosacea treatment system minus metronidazole group were very satisfied (with 70% being satisfied or very satisfied); and 0 percent of the metronidazole plus standard skin care regimen were very satisfied (with 78% being satisfied or very satisfied).

These results suggest that the rosacea treatment system may offer superior efficacy and tolerability, and a greater degree of patient satisfaction, than metronidazole 0.75% plus the standard skin care regimen used in this study. The rosacea treatment system contains several ingredients that were not present in the standard skin care regimen used in this study and which could contribute to this—for example, aloe, licorice, and sea whip (which have been reported to have anti-inflammatory activity),^4-6 lavender (which has been reported to have antibacterial activity),⁷ and mica (which is a light-reflecting mineral and is included to help camouflage erythema). Although it is possible that the clinical superiority of the rosacea treatment system could be attributed to some or all of these ingredients, definitive attributions are not possible—because each study regimen contains multiple ingredients, many of which are present in one regimen but not in the other (Tables 3-4). For example, the rosacea treatment system appears to contain more than 50 ingredients that are not present in the standard skin care regimen—15 contributed by the cleanser and 40 contributed by the hydrating complexion corrector or skin balancing sunscreen (Table 3). Another factor confounding any interpretation of the differences among regimens is the concentration of each ingredient and, as this is proprietary information, such data are not available.

Erythema is one of the key manifestations of rosacea and a lessening in erythema can be one of the most visually obvious changes and one of the most welcomed by patients. In this study, mean erythema levels were significantly different between the rosacea treatment system group and the metronidazole plus standard skin care group at baseline. Nevertheless, it is evident that there was no change in mean erythema levels in the metronidazole plus standard skin care group during the study while the rosacea treatment system group showed a significant reduction from day 14 onward. These results suggest that there could be a synergy among metronidazole and the other components of the rosacea treatment system, because erythema was significantly reduced only in the group whose treatment contained both of these and not in the other groups, each of which contained only one of these. Although it would be valuable to confirm these findings in a split-face study, it is possible that the complexity of maintaining different multi-component regimens on each side of the face could impair patient compliance to such an extent as to prevent meaningful analysis.

Perhaps the largest difference among treatment groups was in the proportion of patients reporting that their skin was easily