Bausch Health Companies Inc.and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, announced that the Journal of Drugs in Dermatology (JDD) published positive results from two large Phase III, multicenter, double-blind, placebo-controlled clinical trials (Studies 1 and 2) demonstrating the efficacy, safety and tolerability of Arazlo (tazarotene) Lotion, 0.045%, the first FDA approved tazarotene in lotion form for patients with moderate to severe acne. A post hoc analysis of male patients in the two Phase III studies was also published by JDD. The FDA has approved Arazlo for the topical treatment of acne vulgaris in patients nine years of age and older in December 2019.
The first primary endpoint in the pivotal studies (Studies 1 and 2) was treatment success (defined as those with at least a two-grade improvement in Evaluator's Global Severity Score (EGSS), and 'clear' or 'almost clear' skin) measured at week 12. The data showed that Arazlo was more effective, with 25.5 percent and 29.6 percent of patients achieving treatment success compared with 13.0 percent and 17.3 percent in the placebo arms of Studies 1 and 2, respectively (p<0.001 for both studies). the second primary endpoint in the pivotal studies was absolute reduction in inflammatory and noninflammatory lesion counts at week 12. the data from studies 1 and 2 showed that arazlo was more effective than placebo, with reductions of 15.6 and 16.7 inflammatory lesion counts from baseline, compared to 12.4 and 13.4 in the placebo arms. non-inflammatory lesion count reductions were 21.0 and 24.6 versus 16.4 and 16.6 in the placebo arms of the two studies, respectively (p><0.001 for both studies). in a pooled analysis of studies 1 and 2, the most common treatment-related adverse events of arazlo compared to placebo were application site pain (5.3 percent vs 0.3 percent), dryness (3.6 percent vs 0.1 percent), exfoliation (2.1 percent in addition to the results from the two phase iii studies, jdd also published results from a post hoc analysis of efficacy in both adult (18 years and older) and adolescent (less than 18 years old) male patients with moderate or severe acne from the phase iii studies. overall, the post hoc analysis found that arazlo was more effective and better tolerated in adult males compared to adolescent males, with better results also reported compared to the overall study population. about the phase iii studies (studies 1 and 2) : studies 1 and 2 were multicenter, double-blind, randomized, placebo-controlled, parallel-group phase iii studies. the studies evaluated the safety, tolerability and efficacy of arazlo (tazarotene) lotion, 0.045%, in 1,614 patients with moderate or severe acne, as determined by the egss. patients were randomized to receive arazlo or placebo lotion, and all patients who were provided the study drug were included in the intent-to-treat (itt) population. the co-primary endpoints were egss and absolute reduction in inflammatory and non-inflammatory lesion counts. patients who had at least a two-grade reduction from baseline egss at week 12, and an egss of 'clear' or 'almost clear' were considered a treatment success. secondary endpoints included percent change in both lesion counts from baseline at each study visit and absolute change in acne-specific quality of life questionnaire (acne-qol) domain scores. safety, adverse events (aes) and cutaneous tolerability were evaluated throughout the study. see- "tazarotene 0.045% lotion for the once-daily treatment of moderate-to-severe acne vulgaris in adult males"- january 2020 | volume 19 | issue 1 | original article | 78 | copyright © january 2020 afran e. cook-bolden md, michael h. gold md, eric guenin pharmd phd mphc .>0.001>0.001>