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Tolerability

Not an actual patient

Highly tolerable1,2 

Soolantra Cream, 1% was more tolerable with twice as many subjects as vehicle

RELATED ADVERSE EVENTS (AEs) occurring in ≥1% of subjects

 

  STUDY 12 STUDY 22
  SOOLANTRA CREAM
(n=452)
VEHICLE CREAM
(n=231)
SOOLANTRA CREAM
(n=458)
VEHICLE CREAM
(n=230)
TOTAL NUMBER OF RELATED AEs 24 25 17 20
TOTAL NUMBER OF SUBJECTS WITH RELATED AEs, n (%)* 19 (4.2) 18 (7.8) 12 (2.6) 15 (6.5)
SKIN BURNING SENSATION 8 (1.8) 6 (2.6) 1 (0.2) 4 (1.7)
SKIN IRRITATION 5 (1.1) 3 (1.3) 1 (0.2) 6 (2.6)
DRY SKIN 1 (0.1) 1 (0.4) - -
SKIN DISCOMFORT - - 0 3 (1.3)
PRURITUS 2 (0.4) 4 (1.7) 3 (0.7) 0
PAIN OF SKIN 1 (0.2) 5 (2.2) 0 1 (0.4)

a A subject was counted once even if the subject experienced more than 1 AE during the study. There were no related serious AEs.

SOOLANTRA CREAM—FORMULATED FOR TOLERABILITY, UTILIZING
CETAPHIL® MOISTURIZING CREAM AS THE BASIS FOR THE VEHICLE2

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 (Investigator's Global Assessment [IGA] score of 3 or 4).1

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 688 subjects with moderate to severe papulopustular rosacea (Investigator's Global Assessment [IGA] score of 3 or 4).2

TREATMENT RELATED ADVERSE EVENTS: PERFORMANCE VS AZELAIC ACID

Lower incidence of treatment-related AEs vs azelaic acid2,3,a

TREATMENT-RELATED ADVERSE EVENTS (AEs) (PART B; SAFETY POPULATION)

  STUDY 12 STUDY 22
  SOOLANTRA CREAM (n=452) AZELAIC ACID
15% GEL(n=231)
SOOLANTRA CREAM
(n=458)
AZELAIC ACID
15% GEL(n=231)
RELATED AES WITH INCIDENCE <0.5%, N (%)        
SKIN BURNING SENSATION 1 (0.3) 1 (0.5) 2 (0.5) 3 (1.4)
SKIN IRRITATION 2 (0.5) 3 (1.4) 1 (0.2) 4 (1.9)
DRY SKIN 2 (0.5) 4 (1.9) 0 2 (1.0)
PRURITIS 0 1 (0.5) 1 (0.3) 4 (1.9)
SKIN DISCOMFORT 0 0 0 2 (1.0)
PAIN OF SKIN 0 5 (2.4) 1 (0.2) 1 (0.5)
HAIR GROWTH ABNORMAL 2 (0.5) 0 0 0
EYE PAIN 0 0 1 (0.2) 1 (0.5)
BLEPHARITIS 0 1 (0.5) 0 0
URINARY TRACT INFECTION 0 1 (0.5) 0 0
ACCIDENTAL EXPOSURE 0 0 0 1 (0.5)
XEROSIS 0 0 0 1 (0.5)

 

SOOLANTRA CREAM’S LOW INCIDENCES OF2:

Dryness (0.5%)         Itching (0.0%)        Stinging/Burning (0.3%)

aA 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 (Investigator’s Global Assessment [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.1,3

The efficacy and safety of Soolantra Cream were evaluated in subjects aged 18 years and older in 2 identically designed phase 3 clinical trials (N=1371). Final results were comparable between the 2 studies, with the safety results from the least favorable efficacy study at Week 52 presented here.1,3

LONG-TERM EFFICACY

Continuous improvement with long-term use1,3

Study results from the second period (Part B),a 40-week extension comparing Soolantra® (ivermectin) Cream, 1% once daily (n=412) with azelaic acid 15% gel twice daily following treatment with vehicle cream once daily (n=210) for 12 weeks (Part A)

Clear or almost clear ratings at Week 403

Percentage of subjects with an IGA score of 0 or 1 (clear or almost clear)

SUBJECTS HAD 12 MORE WEEKS OF TREATMENT WITH SOOLANTRA CREAM ONCE DAILY THAN WITH AZELAIC ACID 15% GEL TWICE DAILY3

 

aThe pivotal trial was divided into 2 periods: Part A (12 weeks) and Part B (40 weeks). In Part A, Soolantra Cream once daily (n=451) was compared with vehicle cream once daily (n=232) for efficacy and safety. In Part B, Soolantra Cream once daily (n=412) was compared with azelaic acid 15% gel twice daily (n=210) to assess long-term safety.1,3

IGA, Investigator’s Global Assessment. Subjects who completed Parts A (N=622) and B (N=526) received Soolantra Cream once daily for a total of 52 weeks (active treatment group) or vehicle cream once daily for 12 weeks followed by azelaic acid 15% gel twice daily for 40 weeks (control group). Efficacy was not a study endpoint for Part B.2,3

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.1,3

The efficacy and safety of Soolantra Cream were evaluated in subjects aged 18 years and older in 2 identically designed phase 3 clinical trials (N=1371). Final results were comparable between the 2 studies, with the least favorable results at Week 52 presented here.1,3

Soolantra Cream application instructions

Instruct patients to:

Apply Soolantra Cream to the affected areas of the face once a day. Use a pea-sized amount of Soolantra Cream for each area of the face (forehead, chin, nose, each cheek) that is affected. Spread as a thin layer across the affected areas of the face, avoiding the eyes and lips.

  • Hands should be washed after applying Soolantra Cream
  • Cosmetics may be applied after Soolantra Cream has dried
  • Soolantra Cream is not for oral, ophthalmic, or intravaginal use