Efficacy

Better and faster results vs MetroCream Topical Cream, 0.75%


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


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

Superior efficacy clearance vs MetroCream Topical Cream, 0.75%1-3,a
PERCENTAGE OF PATIENTS CLEAR* AT END OF TREATMENT (WEEK 16)


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