PMID- 32023013
OWN - NLM
STAT- MEDLINE
DCOM- 20201105
LR  - 20201105
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 19
IP  - 1
DP  - 2020 Jan 1
TI  - Tazarotene 0.045% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne 
      Vulgaris in Adult Males.
PG  - 78-85
LID - S1545961620P0078X [pii]
LID - 10.36849/JDD.2020.3979 [doi]
AB  - BACKGROUND: There has been an increasing interest in gender differences both in 
      the pathogenesis and treatment of acne vulgaris (acne). However, while acne 
      prevalence among adolescents is comparable across sexes, acne is much more common 
      in adult women than in adult men which has been largely ignored. Acne is likely 
      less common in adult men because of the declining rate of sebum secretion 
      observed with increasing age, and yet it can be more severe than in adult women. 
      In addition, adherence to topical medications is especially poor in adult men 
      where tactile and sensory perceptions are low. The first lotion formulation of 
      tazarotene was developed using polymeric emulsion technology to provide an 
      important alternative option to treat these acne patients, especially those who 
      may be sensitive to the irritant effects of other tazarotene formulations. 
      OBJECTIVE: To evaluate the efficacy and safety of a new tazarotene 0.045% lotion 
      formulation based on polymeric emulsion technology in treating adult male 
      subjects with moderate or severe acne, in comparison with adolescent males 
      treated with the same tazarotene 0.045% lotion. METHODS: Post hoc analysis of two 
      multicenter, randomized, double-blind, vehicle-controlled phase 3 studies in 
      moderate-or-severe acne. Subjects (aged 10 and older, N=1614) were randomized 
      (1:1) to receive tazarotene 0.045% lotion or vehicle, once-daily for 12 weeks. 
      Efficacy assessments included changes in baseline inflammatory and 
      noninflammatory lesions and treatment success (at least 2-grade reduction in 
      Evaluator's Global Severity Score [EGSS] and clear or almost clear). Quality of 
      Life was assessed using the validated Acne-QoL scale. Safety, adverse events 
      (AEs) were evaluated throughout; cutaneous tolerability (using a 4-point scale 
      where 0=none and 3=severe) at each study visit. RESULTS: A total of 268 male 
      subjects (85>/=18 years old and 183<18 years old) were treated with tazarotene 
      0.045% lotion once-daily for 12 weeks. At week 12, percent reductions in 
      inflammatory and noninflammatory lesions with tazarotene 0.045% lotion were 62.3% 
      and 59.5% in the adult male population, compared with 49.4% (P=0.001) and 49.5% 
      (P=0.016) in the adolescent male population. Treatment success was achieved by 
      33.0% of adult male subjects treated with tazarotene 0.045% lotion, compared with 
      21.6% in the adolescent male population (P=0.059). Quality of life (as assessed 
      by Acne-QoL domain scores) was better in adolescent males at baseline. 
      Improvements in QoL domain scores were similar to those seen in the overall study 
      population, with greater absolute change in domain scores in the adult males. 
      Improvement in acne symptom scores was significantly greater in adult males 
      (P=0.029). Tazarotene 0.045% lotion was well-tolerated. The number of subjects 
      reporting any AE in the adult male population was 11 (13.6%) compared with 39 
      (21.4%) in the adolescent male population. There was only one (1.2%) 
      treatment-related AE (application site pain) reported in the adult males compared 
      with 11 (6.0%) in the adolescent males, where the most common treatment-related 
      AEs were application site pain (3.3%), dryness (1.1%), and erythema (1.1%). Mean 
      scores for hyper- and hypopigmentation were very low at baseline in both groups 
      with no appreciable change with treatment. CONCLUSIONS: Tazarotene 0.045% lotion 
      provides greater efficacy and better tolerability in adult males (above 18 years 
      old) than the adolescent male population with moderate-to-severe acne patients. J 
      Drugs Dermatol. 2020;19(1):78-85. doi:10.36849/JDD.2020.3979
FAU - Cook-Bolden, Fran E
AU  - Cook-Bolden FE
FAU - Gold, Michael H
AU  - Gold MH
FAU - Guenin, Eric
AU  - Guenin E
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Dermatologic Agents)
RN  - 0 (Nicotinic Acids)
RN  - 81BDR9Y8PS (tazarotene)
MH  - Acne Vulgaris/*drug therapy/pathology
MH  - Administration, Cutaneous
MH  - Adolescent
MH  - Adult
MH  - Age Factors
MH  - Child
MH  - Dermatologic Agents/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Humans
MH  - Male
MH  - Nicotinic Acids/*administration & dosage/adverse effects
MH  - Quality of Life
MH  - Severity of Illness Index
MH  - Skin Cream
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2020/02/06 06:00
MHDA- 2020/11/06 06:00
CRDT- 2020/02/06 06:00
PHST- 2020/02/06 06:00 [entrez]
PHST- 2020/02/06 06:00 [pubmed]
PHST- 2020/11/06 06:00 [medline]
AID - S1545961620P0078X [pii]
AID - 10.36849/JDD.2020.3979 [doi]
PST - ppublish
SO  - J Drugs Dermatol. 2020 Jan 1;19(1):78-85. doi: 10.36849/JDD.2020.3979.