New developments in the treatment of rosacea – role of once-daily ivermectin cream

Figures & data

Table 1 Clinical studies and case reports

Study reference	Patient characteristics	Number of participants	Medication regimen	Study design	Study duration	Findings
Stein et al^Citation2	Subjects >18-year-old males and females; moderate to severe PPR based on IGA; 15–70 facial inflammatory lesions	Study 1 – 683	IVM 1% cream once daily vs vehicle cream once daily	Two multicenter studies of identical design (study 1 and study 2), randomized, double-blinded, parallel, vehicle controlled	12 weeks	IGA success rate
		Study 2 – 688				IVM 1% cream
						Study 1 – 38.4%
						Study 2 – 40.1%
						VC
						Study 1 – 11.6%
						Study 2 – 18.8%
						Adverse events incidence
						IVM 1% cream
						Study 1 – 40.5%
						Study 2 – 36.5%
						VC
						Study 1 – 39.4%
						Study 2 – 36.5%
Stein Gold et al^Citation31	Subjects >18-year-old males and females; moderate to severe PPR based on IGA; 15–70 facial inflammatory lesions	Study 1 – 622	IVM 1% cream once daily vs AzA 15% gel BID	Extension of the above study; initial IVM 1% cream groups continued IVM regimen; initial vehicle cream control group switched to AZA 15% gel twice daily	40 weeks	IVM 1% cream showed increased efficacy in study 1 and study 2
		Study 2 – 636				IGA success rate
						IVM 1% cream
						Study 1 – increased from 38.4% to 71.1% during study duration
						Study 2 – increased from 40.1% to 76.0% during study duration
						Adverse events
						IVM 1% cream
						Majority who received this treatment in both study 1 and study 2 denied treatment-associated stinging, burning, dryness, or itching
						AzA 15% gel
						More patients who received this treatment in both study 1 and study 2 reported treatment-associated stinging, burning, dryness, or itching
Taieb et al^Citation32	Subjects >18-year-old males and females; moderate to severe PPR	960	IVM 1% cream once daily vs MTZ 0.75% cream twice daily	Investigator-blinded, randomized, parallel group study	16 weeks	Percentage reduction of inflammatory lesions
						IVM 1% cream 83.0%
						MTZ 0.75% cream 73.7%
						IGA success rates
						IVM 1% cream 84.9%
						MTZ 0.75% cream 75.4%
						Safety profile
						Comparable between IVM 1% cream and MTZ 0.75% cream. Skin irritation was the most common adverse event
de Macedo et al^Citation35	41-year-old female; gnatophyma (phymatous rosacea affecting chin) × 2 years	1	Single dose, oral IVM 12 mg, TCN 1 g/d, MTZ 1% cream	Case report	N/A	Clinical improvement observed at 1-month follow-up
Brown et al^Citation33	12-year-old female; Demodex folliculorum–associated severe recalcitrant oculocutaneous rosacea	1	Single dose, oral IVM 12 mg (250 μg/kg)	Case report	N/A	Marked improvement in cutaneous symptoms at 1-month follow-up with progressive resolution without additional treatments. Ocular symptom resolution. No recurrence at 2-year follow-up
Allen et al^Citation34	68-year-old male; recalcitrant PPR × 6 years, rosacea-like demodicosis	1	Oral IVM 3mg daily × 8 days, permethrin cream 3 times weekly × 2 weeks (continued for 3 months for maintenance)	Case report	N/A	Marked clinical improvement
Forstinger et al^Citation39	32-year-old male; rosacea-like demodicidosis × 4 years, refractory to conventional treatment	1	Single dose, oral IVM 200 μg/kg, subsequent weekly topical permethrin cream	Case report	N/A	Reduction of pruritus within 2 weeks, reduction of inflammation within 4 weeks
Guerrero-Gonzalez et al^Citation40	7-year-old female; crusted, rosacea-like demodicosis	1	Oral IVM 200 μg/kg weekly for 10 doses, permethrin 5% lotion, 30 mg/kg oral erythromycin divided into three doses (then continued for 2 months), metronidazole cream	Case report	N/A	Clinical resolution after 3 months of treatment

Abbreviations: AzA, azelaic acid; IVM, ivermectin; VC, vehicle control; MTZ, metronidazole; TCN, tetracycline; IGA, investigator’s Global Assessment of Rosacea Severity; PPR, papulopustular rosacea; BID, twice daily; N/A, not applicable.

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