Consistent daily use of oxymetazoline cream is an effective treatment for persistent facial erythema associated with rosacea, according to the results of a post hoc analysis of a previously published phase 3, multicenter, 52-week, open-label study (ClinicalTrials.gov identifier: NCT02095158)2 of once-daily, topical oxymetazoline hydrochloride cream 1.0%. The results of the current post hoc analysis were published in the Journal of the American Academy of Dermatology.1
The current analysis evaluated the proportion of patients who responded to oxymetazoline from day 1 through week 52 and the probability of response between visits. Adults ≥18 years of age with moderate to severe persistent facial erythema of rosacea (ie, grade 3-4 on the Clinician Erythema Assessment [CEA] scale and Subject Self-Assessment for rosacea facial redness [SSA] scale) applied oxymetazoline to their face once daily for 52 weeks.
Based on attainment of composite CEA and SSA ≥1-grade improvement in erythema at any postdose time point on day 1 (3 or 6 hours), or at any point during study visits at week 4, week 26, and week 52 (predose or 3 or 6 hours postdose), increasing proportions of patients were responders to oxymetazoline from day 1 (77.5% of patients) through week 52 (88.5% of patients).
Overall, the proportions of patients with ≥1-grade composite improvement in CEA and SSA at separate points were consistent or increased through week 52. At the 52-week visit, almost 50% of participants fulfilled the responder criteria before applying oxymetazoline. In fact, the likelihood of responding to oxymetazoline therapy generally increased with continued use, even among those patients who did not experience an initial response.
The probability of continued response in initial responders was approximately 90%, while those who were initially nonresponders demonstrated a 44% chance of becoming a responder by week 4. Those with a later transition date (ie switching from nonresponder to responder at week 26 or 52) exhibited a 60% probability of conversion.
Overall, the mean level of response at week 4 either remained the same or increased through the end of the treatment period. Of those participants with 3-grade improvement at week 4, mean CEA and SSA scores did not decline below 2-grade improvement.
The investigators concluded that this post hoc analysis underscores the effect of oxymetazoline for the treatment of persistent facial erythema of rosacea, with long-term, consistent, daily treatment. The probability of response data may help to provide healthcare professionals with evidence to encourage patients to continue the use of once-daily application of oxymetazoline, even among the small subgroup of individuals in whom an initial response may not be observed.
- Gold MH, Lebwohl M, Biesman BS, et al. Daily oxymetazoline cream demonstrates high and sustained efficacy in patients with persistent erythema of rosacea through 52 weeks of treatment [published online May 31, 2018]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2018.05.037
- Draelos ZD, Gold MH, Weiss RA, et al. Efficacy and safety of oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea: Findings from the 52-week open label REVEAL trial. J Am Acad Dermatol. 2018;78(6):1156-1163.