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RAPID RELIEF, CONTINUED
IMPROVEMENT OVER TIME

The efficacy and safety of Soolantra® (ivermectin) Cream, 1% QD was evaluated in 1371 subjects aged ≥18 years in 2 identically designed, phase 3 trials. Final results were comparable between the 2 studies, with the least-favorable results presented here.1

Before and After Soolantra Cream

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  • Subject 8129-008*

    *A phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group study assessing the efficacy and safety of Soolantra Cream in 683 subjects with moderate to severe inflammatory lesions of rosacea (investigator global assessment [IGA] score of 3 or 4).1

  • Subject 8129-012*

    *A phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group study assessing the efficacy and safety of Soolantra Cream in 683 subjects with moderate to severe inflammatory lesions of rosacea (investigator global assessment [IGA] score of 3 or 4).1

  • Subject 5764-010*

    *An investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of Soolantra Cream 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.2,3

  • Subject 5543-005*

    *An investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of Soolantra Cream 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.2,3

  • Subject 8129-008*

    *A phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group study assessing the efficacy and safety of Soolantra Cream in 683 subjects with moderate to severe inflammatory lesions of rosacea (investigator global assessment [IGA] score of 3 or 4).1

  • Subject 8129-012*

    *A phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group study assessing the efficacy and safety of Soolantra Cream in 683 subjects with moderate to severe inflammatory lesions of rosacea (investigator global assessment [IGA] score of 3 or 4).1

  • Subject 5764-010*

    *An investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of Soolantra Cream 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.2,3

  • Subject 5543-005*

    *An investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of Soolantra Cream 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.2,3


Dr. Linda Stein Gold Discusses Soolantra Cream Clinical Data

Dr. Linda Stein Gold is a Galderma consultant and the clinical investigator for the phase 3 efficacy and safety trials of Soolantra Cream in patients with inflammatory lesions of rosacea.

In this video, Dr. Stein Gold reviews the study design and clinical data comparing Soolantra Cream vs vehicle at Week 12, as well as the 40-week extension safety study comparing Soolantra Cream QD vs azelaic acid 15% gel BID.



Significant and Continued Improvements Observed From Weeks 4 Through 121,2


Investigator Global Assessment (IGA) Scale

STRINGENT STUDY CRITERION RAISES THE BAR—MINIMUM 2-GRADE IMPROVEMENT REQUIRED TO ACHIEVE SUCCESS

Success rate, a coprimary end point, was defined as the percentage of subjects with a baseline IGA score of 3 or 4 (moderate or severe) achieving an IGA score of 0 or 1 (clear or almost clear)2

GRADE* SCORE CLINICAL DESCRIPTION
SEVERE 4 Numerous small and/or large papules/pustules, severe erythema
MODERATE 3 Several small or large papules/pustules, moderate erythema
MILD 2 Few small papules/pustules, mild erythema
ALMOST CLEAR 1 Very few small papules/pustules, very mild erythema present
CLEAR 0 No inflammatory lesions present, no erythema

*IGA score was assessed before inflammatory lesion counts.

Significant and Continuous Improvements Observed From Week 4 Through Week 121,2

SUCCESS RATE (IGA 0 OR 1) OF CLEAR OR ALMOST CLEAR (ITT-LOCF)1,2

ITT-LOCF=intent-to-treat, last observation carried forward; QD=once daily.

Rapid and Dramatic Reduction in Inflammatory Lesion Count2

MEAN INFLAMMATORY LESION COUNT REDUCTION AT WEEK 12 (ITT-LOCF)2
  • Mean inflammatory lesion count reduction at week 12 was –20.5 (–64.9%) with Soolantra Cream vs –12.0 (–41.6%) with vehicle (P<0.001)2
    • Mean inflammatory lesion count at baseline was 31 in both groups2
  • Significant inflammatory lesion count reductions continued throughout the entirety of the 12-week trial2

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).

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.



Continuous Improvement With Long-term Use2


More Subjects Were Rated Clear or Almost Clear (IGA Score of 0 or 1) With 1 Year of Soolantra Cream Treatment2

END OF 40-WEEK EXTENSION PHASE: IGA SCORES OF 0 OR 12

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.

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 comparing the long-term 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 studies (N=1371). Final results were comparable between the 2 studies with the least favorable results presented here.

References
  1. Stein Gold L, Kircik L, Fowler J, et al; Ivermectin Phase III Study Group. Efficacy and safety of ivermectin 1% cream in treatment of papulopustular rosacea: results of two randomized, double-blind, vehicle-controlled pivotal studies. J Drugs Dermatol. 2014;13(3):316-323.
  2. Data on file. Galderma Laboratories, L.P.
  3. 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.