In patients with persistent facial erythema associated with rosacea, treatment with topical oxymetazoline and brimonidine is effective for conferring noticeable improvements in erythema, a review article in the Journal of Dermatological Treatment suggests.
The study was an analysis of phase 2 and phase 3 trials that enrolled patients with moderate to severe rosacea who were treated with oxymetazoline and brimonidine topical therapies.
A total of 2 phase 3 trials that assessed efficacy and safety of brimonidine were included (n=553). Clinician erythema assessment (CEA) and subject self-assessment (SSA) were used to assess changes in erythema from baseline. Primary endpoint was the 2-grade improvement on CEA and SSA for facial redness associated with rosacea at post-dose hours 3, 6, 9, and 12 on day 29. In the phase 3 trial, a greater proportion of patients who were treated with brimonidine achieved at least 2-grade or more composite improvement in CEA and SSA vs patients in the vehicle group at each time point (P ≤.02) as well as overall (P <.001).
In a 12-month phase 3 trial, researchers assessed efficacy and safety of a 0.5% brimonidine gel in a similar patient population. There was a gradual reduction in the mean Patient Self-Assessment (PSA) on day 1 at hour 0 to hour 3 from 3.1 to 2.1, respectively. Improvements in erythema, based on the PSA, also decreased from 2.2 to 1.5 at the same time points. Another 8-day randomized, vehicle-controlled study found a 1 grade or more improvement from baseline to day 8 in CEA in patients treated with brimonidine vs vehicle control (71.7% vs 35.7%, respectively; P =.0011). Additionally, a greater proportion of patients treated with brimonidine had an improvement in PSA score (76.1% vs. 47.6%, respectively; P =.004). Topical brimonidine had a good tolerability profile in the overall trials.
Oxymetazoline was evaluated in 2 identical vehicle-controlled phase 3 trials (n=885), which found that the drug was associated with a higher proportion of patients achieving a 2 grade or more composite improvement in CEA and SSA compared with vehicle control (P <.001). Another phase 3 trial of 440 patients with rosacea treated with oxymetazoline found that the therapy was associated with 36.7% and 43.4% of patients achieving a 2-grade improvement in CEA and SSA scores from baseline to hours 3 and 6.
Limitations of the studies in the review were the narrow demographic ranges, the predominantly white patient population, and the lack of longer-term data on the 2 drugs.
According to the authors, addressing the studies’ limitations would “help clinicians to make more informed decisions when using these medications.”
Disclosure: None of the study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Okwundu N, Cline A, Feldman SR. Difference in vasoconstrictors: oxymetazoline vs brimonidine [published online July 11, 2019]. J Dermatolog Treat. doi:10.1080/09546634.2019.1639606