Abstract | 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.
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Authors | Lawrence F Eichenfield, Emil A Tanghetti, Eric Guenin, Gina Martin, Radhakrishnan Pillai |
Journal | Journal of drugs in dermatology : JDD
(J Drugs Dermatol)
Vol. 19
Issue 6
Pg. 602-610
(Jun 01 2020)
ISSN: 1545-9616 [Print] United States |
PMID | 32574011
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Keratolytic Agents
- Nicotinic Acids
- tazarotene
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Topics |
- Acne Vulgaris
(drug therapy, pathology)
- Administration, Cutaneous
- Adolescent
- Child
- Drug Administration Schedule
- Female
- Humans
- Keratolytic Agents
(administration & dosage, therapeutic use)
- Male
- Nicotinic Acids
(administration & dosage, therapeutic use)
- Severity of Illness Index
- Surveys and Questionnaires
- Treatment Outcome
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