PMID- 32574011
OWN - NLM
STAT- MEDLINE
DCOM- 20210413
LR  - 20210413
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 19
IP  - 6
DP  - 2020 Jun 1
TI  - New Polymeric Once-Daily Tazarotene 0.045% Lotion Formulation for 
      Moderate-to-Severe Acne: Pooled Phase 3 Pediatric Analysis.
PG  - 602-610
LID - 10.36849/JDD.2020.10.36849/JDD.2020.4959 [doi]
AB  - 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.
FAU - Eichenfield, Lawrence F
AU  - Eichenfield LF
FAU - Tanghetti, Emil A
AU  - Tanghetti EA
FAU - Guenin, Eric
AU  - Guenin E
FAU - Martin, Gina
AU  - Martin G
FAU - Pillai, Radhakrishnan
AU  - Pillai R
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Keratolytic Agents)
RN  - 0 (Nicotinic Acids)
RN  - 81BDR9Y8PS (tazarotene)
SB  - IM
MH  - Acne Vulgaris/*drug therapy/pathology
MH  - Administration, Cutaneous
MH  - Adolescent
MH  - Child
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Keratolytic Agents/administration & dosage/*therapeutic use
MH  - Male
MH  - Nicotinic Acids/administration & dosage/*therapeutic use
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
EDAT- 2020/06/24 06:00
MHDA- 2021/04/14 06:00
CRDT- 2020/06/24 06:00
PHST- 2020/06/24 06:00 [entrez]
PHST- 2020/06/24 06:00 [pubmed]
PHST- 2021/04/14 06:00 [medline]
AID - S1545961620P0602X [pii]
AID - 10.36849/JDD.2020.10.36849/JDD.2020.4959 [doi]
PST - ppublish
SO  - J Drugs Dermatol. 2020 Jun 1;19(6):602-610. doi: 
      10.36849/JDD.2020.10.36849/JDD.2020.4959.