New Polymeric Once-Daily Tazarotene 0.045% Lotion Formulation for Moderate-to-Severe Acne: Pooled Phase 3 Pediatric Analysis

J Drugs Dermatol. 2020 Jun 1;19(6):602-610. doi: 10.36849/JDD.2020.10.36849/JDD.2020.4959.


Background: Acne vulgaris affects approximately 85% of adolescents. Topical tazarotene is efficacious and safe for acne treatment but irritation limits its use. The objective was to evaluate efficacy, safety, and tolerability of a new tazarotene 0.045% lotion formulation in patients aged 10-13 and 14-17 years with moderate-to-severe acne.

Methods: In two phase 3, double-blind, vehicle-controlled 12-week studies, patients with moderate-to-severe acne (N=1,614) were randomized (1:1) to receive tazarotene 0.045% lotion or vehicle once-daily. Efficacy assessments included changes from baseline in inflammatory/noninflammatory lesions and treatment success (≥2-grade reduction in Evaluator's Global Severity Score [EGSS] and a clear/almost clear score). Quality of life (QoL) and adverse events (AEs) were also assessed.

Results: Patients aged 10-13 years (n=136) and 14-17 years (n=548) were pooled. At week 12, mean percent reductions in inflammatory and noninflammatory lesion counts were significantly greater with tazarotene versus vehicle in both age groups (least-squares mean inflammatory 10-13 years: -55.6 vs -37.0%; 14-17 years: -53.3 vs -41.2%; noninflammatory 10-13 years: -47.7 vs -28.2%; 14-17 years: -52.7 vs -32.9%; P<0.01 all). More patients achieved treatment success with tazarotene versus vehicle in both age groups (P<0.05, both). There were no significant differences between tazarotene-treated age groups in lesion counts or treatment success. Acne-QoL scores at week 12 in both age groups were numerically improved in most domains with tazarotene 0.045% lotion versus vehicle. Most treatment-emergent AEs with tazarotene or vehicle were of mild or moderate severity in both age groups.

Conclusions: Tazarotene 0.045% lotion was efficacious and well tolerated in pediatric patients with moderate-to-severe acne. J Drugs Dermatol. 2020;19(6): doi:10.36849/JDD.2020.4959.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Acne Vulgaris / drug therapy*
  • Acne Vulgaris / pathology
  • Administration, Cutaneous
  • Adolescent
  • Child
  • Drug Administration Schedule
  • Female
  • Humans
  • Keratolytic Agents / administration & dosage
  • Keratolytic Agents / therapeutic use*
  • Male
  • Nicotinic Acids / administration & dosage
  • Nicotinic Acids / therapeutic use*
  • Severity of Illness Index
  • Surveys and Questionnaires
  • Treatment Outcome


  • Keratolytic Agents
  • Nicotinic Acids
  • tazarotene