Efficacy

Not an actual patient

Better and faster results vs MetroCream Topical Cream, 0.75%

Chart showing the percent change in mean reduction of inflammatory lesion counts over 16 weeks with Soolantra at -83.0% vs. MetroCream at -73.7% at week 16. Chart showing the percent change in mean reduction of inflammatory lesion counts over 16 weeks with Soolantra at -83.0% vs. MetroCream at -73.7% at week 16.

IGA, Investigator's Global Assessment; ITT-LOCF, intent ion-to-treat, last observation carried forward.

A phase 3, investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of Soolantra Cream once daily with MetroCream Topical Cream, 0.75% twice daily in 962 subjects aged 18 years and older with moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period.'

In a Head-to-Head Study

IGA success rate criteria1

Chart showing the IGA scale used in the head to head study. Success required a 2 to 3 grade improvement. Chart gives a clinical description for each grade/score. Chart showing the IGA scale used in the head to head study. Success required a 2 to 3 grade improvement. Chart gives a clinical description for each grade/score.

aIGA score was assessed before inflammatory lesion counts.3

A phase 3, investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of Soolantra® (ivermectin) Cream, 1% once daily with MetroCream Topical Cream 0.75% twice daily in 962 subjects aged 18 years and older with moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period.1

Chart showing that 84.9% of patients taking Soolantra were either clear or almost clear at week 16 vs. MetroCream at 75.4%.

Superior efficacy clearance vs MetroCream Topical Cream, 0.75%1-3,a

PERCENTAGE OF PATIENTS CLEAR* AT END OF TREATMENT (WEEK 16)

Chart showing that 60% more subjects achieved an IGA score of 0 with Soolantra vs. MetroCream. Chart showing that 60% more subjects achieved an IGA score of 0 with Soolantra vs. MetroCream.

The most common adverse reactions (incident ≤1%) include skin burning and skin irritation.

aClear (IGA score of 0)=no inflammatory lesions present, no erythema.
IGA, Investigator’s Global Assessment.
84.9% of subjects were rated clear or almost clear with Soolantra Cream once daily vs 75.4% with MetroCream Topical Cream, 0.75%  twice daily (P<0.001).1
A phase 3, investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of Soolantra Cream once daily with MetroCream Topical Cream, 0.75% twice daily in 962 subjects aged 18 years and older with moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period.1

Safety

Low incidence of adverse events vs MetroCream Topical Cream, 0.75%3

TREATMENT-RELATED ADVERSE EVENTS (AEs)

 

  SOOLANTRA (ivermectin)
Cream, 1% ONCE DAILY (n=478)		 METRONIDAZOLE TOPICAL CREAM
0.75% TWICE DAILY (n=484)
TOTAL NUMBER OF RELATED AEs, n 13 25
TOTAL NUMBER OF SUBJECTS WITH RELATED AEs, n(%)* 11 (2.3) 18 (3.7)
SKIN IRRITATION 3 (0.6) 4 (0.8)
ERYTHEMA 2 (0.4) 1 (0.2)
ROSACEA 2 (0.4) 3 (0.6)
PRURITUS 1 (0.2) 2 (0.4)
DERMATITIS ALLERGIC - 2 (0.4)

A phase 3, investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of Soolantra Cream once daily with MetroCream Topical Cream. 0.75% twice daily in 962 subjects aged 18 years and older with moderate to severe papulopustular rosacea (Investigator's Global Assessment [IGA] score of 3 or 4) over a 1 &-week treatment period {Part A). A total of 757 successfully treated subjects, rated clear or almost clear (IGA score of 0 or 1), continued to the 36-week extension evaluating relapse after a treatment-free period (Part B).1,2 

In Part B, subjects were followed every 4 weeks for up to 36 additional weeks (Weeks 16-52). If relapse (defined as IGA score of ≥2 [mild, moderate, or severe]) occurred, subjects were re-treated with the same treatment they had received during the initial 16-week study (Part A). Re-treatment was stopped when subject(s) achieved an IGA of ≤1 (clear or almost clear), with a maximum duration of re-treatment of 16 consecutive weeks to mimic the Part A treatment duration. Several re-treatment periods were permitted.2