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Efficacy

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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 inflammatory lesions of rosacea over a 16-week treatment period, continuing to the 36-week extension evaluating relapse after a treatment-free period. 1,2

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 coparing the long-tern 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 trials (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 (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

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%

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

*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