Favorable safety profile

demonstrated in two Phase 3 studies1

Two PHASE 3 Studies

The most common adverse events were at application site1

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Favorable tolerability was shown with no increase in skin reactions after 2 weeks2

  • Moderate skin reactions peaked at Week 2 at 6.9% (erythema), which decreased to 2.9% by Week 122
  • Severe skin reactions peaked at Week 2 at 0.5% (burning), which decreased to 0.3% by Week 122
  • ARAZLO Lotion is contraindicated in pregnancy. ARAZLO Lotion may cause fetal harm when administered to a pregnant patient1
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 12.3

Phase 2 vs Tazorac Cream 0.1%

45% fewer patients reported a treatment-emergent adverse event with ARAZLO Lotion 0.045% than with Tazorac Cream 0.1%3

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  • The only treatment-related adverse event reported by ≥1% of patients treated with ARAZLO Lotion was application site pain (2.9%)3
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).1

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