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COMPARATIVE STUDIES

The efficacy and safety of Soolantra® (ivermectin) Cream, 1% QD was compared to metronidazole 0.75% cream BID and azelaic acid 15% gel BID in separate, investigator-blinded clinical trials.1,2

Significant Efficacy vs Metronidazole 0.75% Cream BID2

The efficacy and safety of Soolantra Cream QD vs metronidazole 0.75% cream BID was evaluated in subjects with inflammatory lesions of rosacea over a 16-week treatment period.1,2

Significant Results vs Metronidazole 0.75% Cream2

MEAN (%) CHANGE IN INFLAMMATORY LESION COUNTS FROM BASELINE TO WEEK 162

P<0.001

  • A significant difference was shown as early as Week 3 with once-daily Soolantra Cream vs twice-daily metronidazole 0.75% cream (P<0.037) and at every time point thereafter (P<0.001)1,2

Significantly Greater Success Rate vs Metronidazole 0.75% Cream in a Head-to-Head Study2

  • 60% more subjects were clear (investigator global assessment [IGA] score of 0) with once-daily Soolantra Cream (34.9%; n=167) vs twice-daily metronidazole 0.75% cream (21.7%; n=105) P<0.0011,2
SUCCESS RATE OF CLEAR OR ALMOST CLEAR1,2
INCREASED EFFICACY WITH INCREASED SEVERITY
  • 19.5% more subjects with severe inflammatory lesions of rosacea at baseline (IGA score of 4) were rated clear or almost clear (IGA score of 0 or 1) with once-daily Soolantra Cream (82.5%;) n=66) vs twice-daily metronidazole 0.75% cream (63.0%; n=51) at Week 161*

*Post hoc subgroup analysis of success rate at Week 16 to baseline grade.

An investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of Soolantra Cream once daily with metronidazole 0.75% cream twice daily in 962 subjects with moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period.

Soolantra Cream Had a Lower Incidence of Treatment-Related AEs Than Metronidazole 0.75% Cream1

TREATMENT-RELATED AEs OCCURRING IN ≥0.4% OF SUBJECTS1
SOOLANTRA CREAM, 1%
QD
(n=478)
METRONIDAZOLE 0.75% CREAM
BID
(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 0.6% 0.8%
ERYTHEMA 0.4% 0.2%
ROSACEA 0.4% 0.6%
PRURITUS 0.2% 0.4%
DERMATITIS ALLERGIC - 0.4%

*A subject was counted once even if the subject experienced >1 AE during the study.

Study Design

An investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of Soolantra Cream once daily with metronidazole 0.75% cream twice daily in 962 subjects with moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period.



Continuous Improvement With Long-term Use1

More Subjects Were Rated Clear or Almost Clear (IGA Score of 0 or 1) With 1 Year of Soolantra Cream Treatment1

END OF 40-WEEK EXTENSION PHASE: IGA SCORES OF 0 OR 11

The 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 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.

Subjects who completed Parts A and B (N=525) received Soolantra Cream once daily for a total of 52 weeks (active treatment group) or vehicle once daily for 12 weeks followed by azelaic acid 15% gel twice daily for 40 weeks (control group). Efficacy was not a study end point for Part B.

Lower Incidence of Treatment-Related AEs Than Azelaic Acid 15% Gel in a Long-term Safety Study1

TREATMENT-RELATED AEs1
SOOLANTRA CREAM QD AZELAIC ACID 15% GEL BID
Q2
(n=412)
Q3
(n=387)
Q4
(n=371)
Q2
(n=210)
Q3
(n=194)
Q4
(n=186)
TOTAL NUMBER OF RELATED AEs, n (%) 6 4 0 10 4 2
TOTAL NUMBER OF SUBJECTS WITH RELATED AEs, n (%)* 5 (1.2) 3 (0.8) 0 10 (4.8) 4 (2.1) 2 (2.1)
SKIN-BURNING SENSATION 0 1 (0.3) 0 1 (0.5) 0 0
SKIN IRRITATION 2 (0.5) 0 0 3 (1.4) 0 0
DRY SKIN 2 (0.5) 0 0 2 (1.0) 2 (1.0) 0
PRURITUS 0 0 0 0 1 (0.5) 0
HAIR GROWTH ABNORMAL 1 (0.2) 1 (0.3) 0 0 0 0
PAIN OF SKIN 0 0 0 2 (1.0) 1 (0.5) 2 (1.1)
BLEPHARITIS 0 0 0 1 (0.5) 0 0
HEPATIC ENZYME INCREASED 0 1 (0.3) 0 0 0 0
URINARY TRACT INFECTION 0 0 0 1 (0.5) 0 0

*A subject was counted once even if the subject experienced >1 AE during the study.

  • Fewer subjects reported dermatologic AEs—skin-burning sensation, skin irritation, dry skin, pain of skin—with Soolantra Cream vs azelaic acid 15% gel1

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.

Study Design

A phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group study assessing the efficacy and safety of Soolantra Cream, 1% once daily in 683 subjects with moderate to severe papulopustular rosacea (IGA score of 3 or 4), followed by a 40-week, invesigator-blinded extension comparing the long-term safety of Soolantra Cream, 1% once daily with azelaic acid 15% gel twice daily in 622 subjects.

The efficacy and safety of Soolantra Cream, 1% 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.

References
  1. Data on file. Galderma Laboratories, L.P.
  2. Taieb A, Ortonne JP, Ruzicka T, et al; Ivermectin Phase III Study Group. Superiority of ivermectin 1% cream over metronidazole 0.75% cream in treating inflammatory lesions of rosacea: a randomized, investigator-blinded trial. Br J Dermatol. In press.