Tazarotene Lotion Benefit for Acne Does Not Differ by Season

Zoe D. Darealos, MD

Credit: Facebook

Lower-dose tazarotene lotion was associated with consistent efficacy for the treatment of moderate to severe acne, regardless of season during which patients were treated, according to new data.¹

In a post hoc analysis of a pair of phase 3 trials involving patients ≥9 years old with moderate to severe acne, a multinational team of investigators observed consistent resolution of inflammatory and non-inflammatory lesions in patients treated with tazarotene 0.045% in both winter and summer months. The data, presented at the Maui Derm 2023 NP + PA Summer Conference in Colorado Springs this week, provide assurance for the investigative acne treatment’s year-round—a factor that often plays into acne severity and treatment outcomes.

Led by Zoe D. Darealos, MD, of Dermatology Consulting Services in High Point, NC, investigators sought to evaluate the efficacy and safety of tazarotene lotion 0.045% in patients with moderate to severe acne by season.

“Skin health can vary by season, causing increased winter-time dryness, scaling, erythema, and irritation,” investigators wrote. “This seasonal variability may exacerbate cutaneous irritation associated with some topical retinoids, especially older formulations of tazarotene gel and cream, thereby impacting patient adherence and subsequent treatment success.”

The assessed lower-dose tazarotene 0.045% lotion formulation was developed through polymeric emulsion; the previous double-blind, randomized, 12-week phase 3 trials involving the formulation showed it was associated with fewer adverse events and improved efficacy for the treatment of moderate to severe acne than a 0.1% cream formulation.²

For the post hoc analysis, Darealos and colleagues observed trial participants randomized 1:1 to either once-daily tazarotene or vehicle cream. They stratified the 1614 observed patients based on their randomization date to interpret seasonal-based effect of therapy: the “summer” arm included patients initiating care from May – September; the “winter” arm included patients initiating care from October – April.

Investigators’ primary endpoints were inflammatory or noninflammatory lesions and treatment success per a ≥2-grade reduction in Evaluator’s Global Severity Score (EGSS) from baseline, and a score of “clear” or “almost clear” skin. They also sought safety outcomes including treatment-emergent adverse events (TEAEs) and cutaneous outcomes.

Versus vehicle, tazarotene 0.045% was associated with significant improvement in moderate to severe acne through 12 weeks, regardless of season. Mean absolute reductions for inflammatory lesions were as follow:

• Winter patients given tazarotene: -16.6
• Winter patients given vehicle: -13.2
• Summer patients given tazarotene: -15.8
• Summer patients given vehicle: -12.9

Mean absolute reductions for non-inflammatory lesions were as follow:

• Winter patients given tazarotene: -23.2
• Winter patients given vehicle: -17.5
• Summer patients given tazarotene: -22.6
• Summer patients given vehicle: -15.1

Investigators also noted 30.1% of winter patients receiving tazarotene achieved treatment success per EGSS, versus 18.2% of those receiving vehicle. Another 30.8% of summer patients receiving treatment achieved the EGSS benchmark, versus 17.6% of summer patients receiving vehicle.

“Similarly, no strong seasonal trends in safety were observed, though tazarotene treatment led to slightly more winter-time discontinuations (3.4% vs 1.9%) and related AEs (12.0% vs 10.3%) than summer,” investigators wrote.

The team added that the transient increases in rates of scaling, erythema and itching from weeks 2 – 8 of the assessment were slightly higher in patients receiving tazarotene in the winter versus the summer, but the values of outcomes were near equal by week 12.

“Tazarotene 0.045% lotion was efficacious in treating moderate-to-severe acne, regardless of season,” investigators concluded. “Though some slight transient increases in cutaneous events were observed in the winter, tazarotene lotion was well tolerated across seasons.”

References

1. ^{Draelos ZD, Tanghetti EA, Gooderham MJ, Alexis A. Impact of Seasonal Variation on the Efficacy and Safety of Tazarotene 0.045% Lotion for Acne: Post Hoc Analysis of Pooled Phase 3 Data. Poster presented at: Maui Derm 2023 NP + PA Summer Conference, Colorado Springs, CO, June 22 – 25, 2023.}
2. ^{Tanghetti EA, Werschler WP, Lain T, Guenin E, Martin G, Pillai R. Tazarotene 0.045% Lotion for Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris: Results from Two Phase 3 Trials. J Drugs Dermatol. 2020;19(1):70-77. doi:10.36849/JDD.2020.3977}