Efficacy

Not an actual patient

Better results with Soolantra® (ivermectin) Cream, 1% vs MetroCream Topical Cream, 0.75% confirmed in the first and only large-scale rosacea relapse study1

The efficacy and safety of Soolantra Cream QD and MetroCream Topical Cream, 0.75% BID was evaluated in subjects with inflamatory lesions of rosacea over a 16-week treatment period, continuing to the 36-week extension evaluating relapse after a treament-free period. 1,2

In a head to head trial with MetroCream Topical Cream, nearly 1 out of 3 Soolantra patients remained clear or almost clear at 1 year and 33% more subjects had no rosacea relapse with Soolantra vs. MetroCream. In a head to head trial with MetroCream Topical Cream, nearly 1 out of 3 Soolantra patients remained clear or almost clear at 1 year and 33% more subjects had no rosacea relapse with Soolantra vs. MetroCream.

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

Study Design

A phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group study assessing the efficacy and safety of Soolantra Cream once daily in 683 subjects with moderate to severe papulopustular rosacea (IGA score of 3 or 4), followed by a 40-week, investigator-blinded extension comparing the long-term safety of Soolantra Cream once daily with azelaic acid 15% gel twice daily in 622 subjects.

The efficacy and safety of Soolantra Cream once daily was evaluated in subjects aged ≥18 years in 2 identically designed phase 3 clinical studies (N=1371). Final results were comparable between the 2 studies with the least favorable results presented here.

*Clinical success was defined as achieving clear or almost clear.

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 16-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 a?er 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 IGS 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.1

Patient Photos

36-week extension study to assess subjects after 16 weeks of successful treatment (IGA score of 0 or 1)1

More subjects were rated clear or almost clear and maintained that success post-treatment with Soolantra® (ivermectin) Cream, 1% vs MetroCream Topical Cream, 0.75%

Photos of study subject's progress at weeks 16, 32, and 52 from baseline. IGA Score at baseline 3/moderate, week 16 1/almost clear, week 32 2/mild, and week 52 1/almost clear. Photos of study subject's progress at weeks 16, 32, and 52 from baseline. IGA Score at baseline 3/moderate, week 16 0/clear, week 32 0/clear, and week 52 1/almost clear.

IGA, Investigator’s Global Assessment.

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 (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.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 (IGA score of 3 or 4) over a 16-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.1

Longer Time to Relapse

Significantly longer time to first relapse1

Image showing patients using Soolantra had 115 days to first relapse vs. MetroCream with 85 days to first relapse. Image showing patients using Soolantra had 115 days to first relapse vs. MetroCream with 85 days to first relapse.

*Time to first relapse was defined as the time elapsed between Week 16 (end of Part A) and the first relapse (IGA ≥2) during Part B.

IGA, Investigator’s Global Assessment.

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 (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.1