Tolerability

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 EITH 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 IRRITAION | 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 IRRITATIN | 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