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Tazarotene 0.045% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris

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eMediNexus    14 August 2020

Although acne prevalence among adolescents is comparable across sexes, acne is much more common in adult women than in adult men. Acne is likely less common in adult men because of the declining rate of sebum secretion observed with increasing age. However, in men acne can be more severe than in adult women. In addition, adherence to topical medications is especially poor in adult men where tactile and sensory perceptions are low.

The first lotion formulation of tazarotene was developed using polymeric emulsion technology to provide an important alternative option to treat these acne patients, especially those who may be sensitive to the irritant effects of other tazarotene formulations.

A new study published in the Journal of Drugs in Dermatology evaluated the efficacy and safety of a new tazarotene 0.045% lotion formulation based on polymeric emulsion technology in treating adult male subjects with moderate or severe acne, in comparison with adolescent males treated with the same tazarotene 0.045% lotion.

In this post hoc analysis of two multicenter, randomized, double-blinded, vehicle-controlled phase 3 studies in moderate-or-severe acne, 1 614 subjects, aged 10 years and older were randomized (1:1) to receive tazarotene 0.045% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success – determined by at least 2-grade reduction in Evaluator’s Global Severity Score [EGSS] and clear or almost clear. The Quality of Life was assessed using the validated Acne-QoL scale.

Overall, 268 male adults and adolescents were treated with tazarotene 0.045% lotion once-daily for 12 weeks. It was noted that at week 12, percent reductions in inflammatory and noninflammatory lesions with tazarotene 0.045% lotion were 62.3% and 59.5% in the adult male population, compared with 49.4% and 49.5% in the adolescent male population. Treatment success was achieved by 33% of adult males treated with tazarotene 0.045% lotion, compared with 21.6% in the adolescent male population. Furthermore, improvements in QoL domain scores were similar to those seen in the overall study population, with greater absolute change in domain scores among adult males. While improvement in acne symptom scores was significantly greater in adult males. Tazarotene 0.045% lotion was well-tolerated.

Meanwhile, there was only one treatment-related adverse event (AE) – application site pain, reported amongst adult males, andnumber of subjects reporting any AE was lower among the adult male population. The mean scores for hyper- and hypopigmentation were very low at baseline in both groups with no appreciable change with treatment.

Thus, it was inferred that tazarotene 0.045% lotion provides greater efficacy and better tolerability in adult males than the adolescent male population with moderate-to-severe acne.

Source: Journal of Drugs in Dermatology. 2020 Jan 1;19(1):78-85. doi: 10.36849/JDD.2020.3979.

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