Tazarotene lotion nets FDA approval for acne treatment

  • US Food and Drug Administration

  • von Brian Richardson, PhD
  • Clinical Essentials
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Takeaway

  • Tazarotene lotion 0.045% (Ortho Dermatologics) has been approved by the FDA for topical treatment of acne vulgaris in patients aged 9 years and older.

Why this matters

  • This is the first approved tazarotene acne treatment available in lotion form.
  • Tazarotene in different formulations is approved for various indications in Europe.

Key information

  • Approval was based on data from 2 phase 3 randomized controlled trials.
    • In both trials, tazarotene lotion 0.045% was associated with the attainment of primary efficacy endpoints (P<.001>
    • Tazarotene lotion 0.045% was generally well-tolerated in the clinical study population.
  • The 2 phase 3 trials included 1614 patients with moderate to severe acne.
  • In a separate phase 2 trial, tazarotene lotion 0.045% showed similar treatment success rates and lesion reduction rates as tazarotene cream 0.1%.