Topical Ivermectin Effective for Mild to Moderate Inflamed Rhinophyma, Study Finds

"Applying 1% ivermectin cream twice daily seems to be an effective treatment for patients with mild to moderate inflamed rhinophyma, with 60% of patients achieving clear or nearly clear skin," the researchers wrote in their study published in the Journal of the American Academy of Dermatology.

According to the ROSacea COnsensus panel, inflamed rhinophyma is a distinct rosacea marked by erythema, prominent dilated pilosebaceous pores, and recurrent papules or pustules. Managing this condition remains difficult due to the lack of a specific approved drug for treatment. Giuseppe Micali, University of Catania, Catania, Italy, and colleagues aimed to assess the efficacy and tolerability of ivermectin 1% cream applied once or twice daily compared to metronidazole (MTZ) 0.75% gel used twice daily—both treatments approved for inflammatory rosacea—a 12-week evaluation was conducted in patients with mild to moderate inflamed rhinophyma.

For this purpose, the researchers conducted a randomized controlled trial with 50 new adult patients (40 males, 10 females; mean age 62.7 years) suffering from mild to moderate nasal rhinophyma, characterized by erythema and papules/pustules. Participants were randomly assigned to receive either IVM 1% cream once daily (20 patients), IVM 1% cream twice daily (20 patients), or MTZ 0.75% gel twice daily (10 patients) in a 1:1:1 ratio.

To minimize bias, a blinded investigator-assessed all patients at baseline, eight weeks, and 12 weeks. Clinical evaluations included erythema severity and overall efficacy, while instrumental assessments were conducted using erythema-directed digital photography. Tolerability and cosmetic acceptability were measured with a self-administered questionnaire. Data were analyzed using SPSS software, and patients with clear or nearly clear responses had a follow-up visit at eight weeks.

The following were the revelations of the study:

• At week 8, a statistically superior success profile from the baseline of Investigator Erythema Severity Assessment (from mean 2 ± 0.64 to 1.45 ± 0.75) and erythema-directed digital photography scores (from mean 2.35 ± 0.58 to 1.5 ± 0.82) was observed with IVM twice daily compared with both IVM once daily and MTZ twice daily.
• At week 12, additional significant clinical (Investigator Erythema Severity Assessment: mean from 2 ± 0.64 to 1.1 ± 0.64) and instrumental (erythema-directed digital photography: mean from 2.35 ± 0.58 to 1.5 ± 0.82) improvement was seen.
• These results were consistent with those from Investigator Global Assessment, which showed, for IVM once or twice daily or MTZ twice daily: clear in 10% versus 25% versus 20% and almost clear in 25% versus 35% versus 0% of patients, respectively.
• All regimens were safe and well tolerated, and no dropouts were observed.
• Follow-up showed that patients treated with IVM twice daily were able to maintain the results for a longer time (36 days) compared with those treated with IVM once daily (25 days) and MTZ twice daily (18 days).

Despite these promising results, the study acknowledges several limitations. Conducted as an open-label, single-center trial without a placebo group, it involved a relatively small patient cohort.

"As a result, while the findings are encouraging, further research involving larger, placebo-controlled trials is necessary to validate these results and assess the broader applicability of ivermectin for rhinophyma treatment," the researchers concluded.

Reference:

Dall'Oglio F, Nasca MR, Vitale P, Platania H, Micali G. Inflamed rhinophyma treated with topical ivermectin: A randomized controlled study. J Am Acad Dermatol. 2024 Sep;91(3):519-521. doi: 10.1016/j.jaad.2024.03.051. Epub 2024 Apr 30. PMID: 38697218.