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Efficacy

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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 123,4

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

Rapid and Dramatic Reduction in Inflammatory Lesion Count5

  • 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), followed by a 40-week, investigator-blinded extension comparing the long-tern 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 trials (N=1371). Final results were comparable between the 2 studies with the least favorable results presented here.

The most common adverse reactions (incidence ≤ 1%) included skin burning sensation and skin irritation.

The Results Are Clear—Powerful inflammatory lesion reductions1

SUBJECT 009

IGA, Investigator’s Global Assessment. A phase 3, investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of Soolantra® (ivermectin) Cream, 1% once daily with MetroCream Topical Cream, 0.75% twice daily in 962 subjects aged 18 years and older with moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period.1

SUBJECT 005

IGA, Investigator’s Global Assessment. A phase 3, investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of Soolantra® (ivermectin) Cream, 1% once daily with MetroCream Topical Cream, 0.75% twice daily in 962 subjects aged 18 years and older with moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period.1

SUBJECT 019

IGA, Investigator’s Global Assessment. A phase 3, investigator-blinded, multicenter, randomized, parallel-group study comparing the efficacy and safety of Soolantra® (ivermectin) Cream, 1% once daily with MetroCream Topical Cream, 0.75% twice daily in 962 subjects aged 18 years and older with moderate to severe papulopustular rosacea (IGA score of 3 or 4) over a 16-week treatment period.1

Sample population representing treatment failure vs vehicle cream2 

SUBJECT 006

IGA, Investigator’s Global Assessment. A phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group study assessing the efficacy and safety of Soolantra® (ivermectin) Cream, 1% once daily in 683 subjects with moderate to severe papulopustular rosacea (IGA score of 3 or 4).3

SUBJECT 008

IGA, Investigator’s Global Assessment. A phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group study assessing the efficacy and safety of Soolantra® (ivermectin) Cream, 1% once daily in 683 subjects with moderate to severe papulopustular rosacea (IGA score of 3 or 4).3

SUBJECT 014

IGA, Investigator’s Global Assessment. A phase 3, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group study assessing the efficacy and safety of Soolantra® (ivermectin) Cream, 1% once daily in 683 subjects with moderate to severe papulopustular rosacea (IGA score of 3 or 4).3

Safety

  SOOLANTRA (ivermectin)
Cream, 1% ONCE DAILY (n=478)
METRONIDAZOLE TOPICAL CREAM
0.75% TWICE DAILY
(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 3 (0.6) 4 (0.8)
ERYTHEMA 2 (0.4) 1 (0.2)
ROSACEA 2 (0.4) 3 (0.6)
PRURITUS 1 (0.2) 2 (0.4)
DERMATITIS ALLERGIC - 2 (0.4)

A greater percentage of subjects on vehicle/azelaic acid had treatment related AEs vs subjects using Soolantra Cream 
No severe or serious AEs were considered related to Soolantra Cream or A2A. Five subjects in Soolantra Cream group and 4 subjects in the AzA group discontinued from the study due to an AE during Part B. None of the AEs that led to discontinuation in the Soolantra Cream group were considered related to Soolantra Cream 
*A Subject was counted once even if the subject experienced more than 1 AE during the study