Two PHASE 3 Studies

UP TO 60% MEAN REDUCTION IN NONINFLAMMATORY LESIONS AT WEEK 121

ARAZLO Lotion efficacy in inflammatory and noninflammatory acne was studied in two Phase 3 trials

PRIMARY ENDPOINT: Mean absolute reduction in noninflammatory lesions with ARAZLO Lotion was -21.0 vs -16.4 for vehicle in study 1 and -24.6 vs -16.6, respectively, in study 2 (P<0.001 in both trials)1,2*

Study design
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The safety and efficacy of once-daily ARAZLO Lotion were assessed in 2 multicenter, randomized, double-blind Phase 3 clinical trials of 1,614 subjects 9 years of age and older with facial acne vulgaris. Enrolled subjects had a score of moderate (3) or severe (4) on the Evaluator’s Global Severity Score (EGSS), 20 to 50 inflammatory lesions (papules, pustules, and nodules), 25 to 100 noninflammatory lesions (open and closed comedones), and 2 or fewer facial nodules. The coprimary efficacy endpoints of success on the EGSS, absolute change in noninflammatory lesion count, and absolute change in inflammatory lesion count were assessed at Week 12.1

ARAZLO Lotion efficacy in inflammatory and noninflammatory acne was studied in two Phase 3 trials

UP TO 60% MEAN REDUCTION IN INFLAMMATORY LESIONS AT WEEK 121

In two Phase 3 studies, ARAZLO Lotion 0.045% provided clearance for noninflammatory and inflammatory acne

PRIMARY ENDPOINT: Mean absolute reduction in inflammatory lesions with ARAZLO Lotion was -15.6 vs -12.4 for vehicle in study 1 and -16.7 vs -13.4, respectively, in study 2 (P<0.001 in both trials)1,2*

Study design
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The safety and efficacy of once-daily ARAZLO Lotion were assessed in 2 multicenter, randomized, double-blind Phase 3 clinical trials of 1,614 subjects 9 years of age and older with facial acne vulgaris. Enrolled subjects had a score of moderate (3) or severe (4) on the Evaluator’s Global Severity Score (EGSS), 20 to 50 inflammatory lesions (papules, pustules, and nodules), 25 to 100 noninflammatory lesions (open and closed comedones), and 2 or fewer facial nodules. The coprimary efficacy endpoints of success on the EGSS, absolute change in noninflammatory lesion count, and absolute change in inflammatory lesion count were assessed at Week 12.1

In two Phase 3 studies, ARAZLO Lotion 0.045% provided clearance for noninflammatory and inflammatory acne

Up to 30% of patients had clear or almost clear skin at week 121

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Post-hoc analysis of two Phase 3 studies revealed comparable treatment
success in a range of skin types2:

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of Hispanic patients
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of non-Hispanic patients
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of Black or African American patients
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of Caucasian patients
Study design
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The safety and efficacy of once-daily ARAZLO Lotion were assessed in 2 multicenter, randomized, double-blind Phase 3 clinical trials of 1,614 subjects 9 years of age and older with facial acne vulgaris. Enrolled subjects had a score of moderate (3) or severe (4) on the Evaluator’s Global Severity Score (EGSS), 20 to 50 inflammatory lesions (papules, pustules, and nodules), 25 to 100 noninflammatory lesions (open and closed comedones), and 2 or fewer facial nodules. The coprimary efficacy endpoints of success on the EGSS, absolute change in noninflammatory lesion count, and absolute change in inflammatory lesion count were assessed at Week 12.1

*The LS means, SDs, and P-values were obtained from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center, and the respective baseline lesion count as covariate. Values have been adjusted for multiple imputation.2

‡Treatment success on the Evaluator’s Global Severity Score (EGSS) was defined as at least a 2-grade improvement from baseline and an EGSS score of clear (0) or almost clear.1
LS=least squares; SD=standard deviation.

Phase 2 vs Tazorac Cream 0.1%

Comparable efficacy to Tazorac Cream 0.1% at less than half the concentration3

Mean Noninflammatory Lesion Reductions at Week 121,3

57%

ARAZLO LOTION 0.045%

(N=69)
VS

P=0.637

54%

TAZORAC CREAM 0.1%

(N=72)
35% reduction in mean noninflammatory lesions with combined vehicle (N=69)

Mean Inflammatory Lesion Reductions at Week 121,3

64%

ARAZLO LOTION 0.045%

(N=69)
VS

P=0.556

60%

TAZORAC CREAM 0.1%

(N=72)
51% reduction in mean inflammatory lesions with combined vehicle (N=69)
Study design
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The safety and efficacy of ARAZLO Lotion were assessed in a multicenter, randomized, double-blind, vehicle-controlled Phase 2 clinical trial of 210 subjects aged 12 years and older with acne vulgaris. Subjects had a score of moderate (3) or severe (4) on the Evaluator’s Global Severity Score (EGSS), 20 to 40 inflammatory lesions, 20 to 100 noninflammatory lesions, and 2 nodules or less. Subjects were randomized to receive ARAZLO Lotion 0.045%, tazarotene cream 0.1%, or respective vehicle. The Week 12 coprimary endpoints included: mean absolute change in inflammatory and noninflammatory lesion counts; and percentage of subjects with at least a 2-grade reduction in EGSS and scores of clear (0) or almost clear(1).3

ARAZLO Lotion 0.045% demonstrated increased tolerability over Tazorac Cream 0.1%3

  • 45% fewer patients reported a treatment-emergent adverse event with ARAZLO Lotion 0.045% (14.7%) than Tazorac Cream 0.1% (26.8%)3
  • Incidence of treatment-related adverse events was low with ARAZLO Lotion (2.9%) compared with Tazorac Cream 0.1% (4.2%)3
Study design
close

The safety and efficacy of ARAZLO Lotion were assessed in a multicenter, randomized, double-blind, vehicle-controlled Phase 2 clinical trial of 210 subjects aged 12 years and older with acne vulgaris. Subjects had a score of moderate (3) or severe (4) on the Evaluator’s Global Severity Score (EGSS), 20 to 40 inflammatory lesions, 20 to 100 noninflammatory lesions, and 2 nodules or less. Subjects were randomized to receive ARAZLO Lotion 0.045%, tazarotene cream 0.1%, or respective vehicle. The Week 12 coprimary endpoints included: mean absolute change in inflammatory and noninflammatory lesion counts; and percentage of subjects with at least a 2-grade reduction in EGSS and scores of clear (0) or almost clear(1).3

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