Researchers have found that once-daily tazarotene 0.045% is efficacious with a favorable safety and tolerability profile for the treatment of moderate to severe acne. The results of a pivotal, 12-week, phase 3 study were shared as a poster abstract at the American Academy of Dermatology Virtual Meeting Experience 2020.
In the trial (NCT03168321), patients aged 9 years and older were randomized 1:1 to once-daily application of either tazarotene 0.045% or a vehicle lotion for a 12-week period. The study primary endpoints were change from baseline to week 12 in mean inflammatory and noninflammatory lesion counts and treatment success (defined as percentage of patients who achieved ≥ 2-grade reduction from baseline at week 12 in Evaluator’s Global Severity Score and a score of clear or almost clear). Study participants (N=813; experimental group, n=411; control, n=402) were comprised of 67.8% women and 72.6% white patients and had a mean age of 20.6 years.
At the trial conclusion, the percent changes from baseline to week 12 in inflammatory and noninflammatory lesion counts were significantly greater with the experimental group vs control. For inflammatory lesions, the experimental lotion saw least squares mean percent change from baseline of -27.3, -45.3, and -55.5 vs -29.7, -39.0, and -45.7 for control in weeks 4, 8, and 12, respectively. In noninflammatory lesions, least squares mean percent change from baseline was -29.3, -43.1, and -51.4 for tazarotene 0.045% vs -23.3, -34.3, and -41.5 for control in weeks 4, 8, and 12, respectively. In addition, 25.5% of experimental participants achieved treatment success at week 12 vs only 13.0% of controls.
As for safety, the most common treatment-emergent adverse events in the tazarotene group were mild or moderate severity, including pain, dryness, erythema, and exfoliation. Further, there were transient increases in scaling, erythema, itching, burning, and stinging which peaked at week 2, though all cutaneous safety and tolerability scores were mild and generally similar to baseline by the end of the trial.
The researchers noted that these study results are similar to those of another pivotal phase 3 trial of tazarotene 0.045% lotion for the treatment of moderate to severe acne.
Tanghetti EA, Lain E, Green LJ, Martin G, Pillai R, Guenin E. Phase 3 study (301) of tazarotene 0.045% lotion for once-daily treatment of moderate-to-severe acne vulgaris. Presented at: American Academy of Dermatology Virtual Meeting Experience; June 12-14, 2020.
Once-Daily Tazarotene Formula 0.045% Effective for Moderate to Severe Acne