SOOLANTRA Cream— Formulated for tolerability, utilizing CETAPHIL® Moisturizing Cream as the basis for the vehicle8
Tolerability
Not an actual patient
A well-tolerated formulation1-5
Offering efficacy without compromising safety and tolerability
More tolerable than vehicle, with twice as many subjects3
Similar safety and tolerability vs METROCREAM (metronidazole) Topical Cream, 0.75%1,2,4
Lower incident of TAEs* vs azelaic acid6
*TAEs, treatment-related adverse events
Highly tolerable7,8
SOOLANTRA® (ivermectin) Cream, 1% was more tolerable with twice as many subjects as vehicle
RELATED ADVERSE EVENTS (AEs) occurring in ≥1% of subjects
| STUDY 18 | STUDY 28 | |||
| 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 subject was counted once even if the subject experienced more than 1 AE during the study. There were no related serious AEs.
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).7
Lower incidence of treatment-related AEs vs azelaic acid8,9,a
TREATMENT-RELATED ADVERSE EVENTS (AEs) (STUDY 2; SAFETY POPULATION)
| STUDY 18 | STUDY 28 | |||
| 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 OF:8
Dryness (0.5%) Itching (0.0%) Stinging/Burning (0.3%)
Continuous improvement with long-term use7,9
Study results from the second period (Study 2),a 40-week extension comparing SOOLANTRA Cream once daily (n=412) with azelaic acid 15% gel twice daily following treatment with vehicle cream once daily (n=210) for 12 weeks (Study 1)
Percentage of subjects with an IGA score of 0 or 1 (clear or almost clear)
aThe pivotal trial was divided into 2 periods: Study 1 (12 weeks) and Study 2 (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 Study 2, SOOLANTRA Cream once daily (n=412) was compared with azelaic acid 15% gel twice daily (n=210) to assess long-term safety.7,9
Subjects who completed Study’s 1 (N=622) and 2 (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 Study 2.8,9
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.7,9
IGA=Investigator’s Global Assessment.
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.7,9
Knowing there is an innovative treatment available to keep my rosacea bumps and blemishes under control is really encouraging and exciting†
Not an actual patient
†Individual results may vary
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
