PMID- 31741356
OWN - NLM
STAT- MEDLINE
DCOM- 20200130
LR  - 20211204
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 18
IP  - 11
DP  - 2019 Nov 1
TI  - Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne 
      Vulgaris: Impact of Gender and Race on Efficacy and Safety.
PG  - 1128-1138
LID - S1545961619P1128X [pii]
AB  - Background: There has been an increasing interest in gender and racial 
      differences both in the pathogenesis and treatment of acne vulgaris (acne), and 
      postinflammatory hyperpigmentation (PIH) is a major concern in patients of color. 
      Female acne patients report more anxiety and depression with acne improvement 
      positively influencing Quality of Life (QoL) than their male counterparts, and 
      there are differences in acne presentation. The first lotion formulation of 
      tretinoin was developed using novel 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 tretinoin formulations. 
      Objective: To determine the impact of gender and race on the efficacy and safety 
      of tretinoin 0.05% lotion in treating moderate or severe acne. Methods: Post hoc 
      analysis of 2 multicenter, randomized, double-blind, vehicle-controlled Phase 3 
      studies in moderate-to-severe acne. Subjects (aged 9 to 58 years, N=1640) were 
      randomized (1:1) to receive tretinoin 0.05% 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/almost clear). Quality of Life 
      was assessed using the validated Acne QoL scale. Safety, adverse events (AEs), 
      cutaneous tolerability, and hypo-/hyper-pigmentation (using a 4-point scale where 
      0=none and 3=severe) were evaluated at each study visit. Results: At week 12, 
      mean percent reduction in inflammatory lesion counts were 56.9% and 53.4% 
      respectively in female and male patients compared with 47.1% and 39.4% with 
      vehicle (P</=0.001), with females statistically significant to males at week 8 
      [P=0.026]). Mean percent reduction in noninflammatory lesion counts in females 
      and males were 51.7% and 46.1% respectively, compared with 34.9% and 29.7% with 
      vehicle (P<0.001), with females statistically significant to males at week 12 
      (P=0.035). Treatment success was achieved by 23.6% and 16.1% of female and male 
      patients treated with tretinoin 0.05% lotion by week 12 (P</=0.001 vs vehicle) with 
      females statistically significant compared with males (P=0.013). Significant 
      differences in inflammatory lesion count reductions were reported in Caucasian 
      patients from week 8, and Black African/American male patients at week 12. Only 
      male patients reported significant differences in both races in terms of 
      noninflammatory lesions, and only Caucasian patients reported significant 
      differences in treatment success. Female patients treated with tretinoin 0.05% 
      lotion had statistically significant improvements in each Acne QoL domain (except 
      role-social) compared with vehicle. Improvements in QoL in male subjects were 
      only statistically different for acne symptoms. Tretinoin 0.05% lotion was 
      well-tolerated in both genders. There were more treatment-related AEs in the 
      female subpopulation, with a significantly greater incidence of skin dryness 
      (P=0.006), that was more common in the younger Caucasian females. Conclusions: 
      Tretinoin 0.05% lotion has been shown to be effective and well tolerated in 
      moderate-to-severe acne. Treatment was significantly more effective in females 
      than males. Tretinoin 0.05% lotion was well tolerated by both genders, although 
      there was a higher incidence of treatment-related AEs, especially skin dryness, 
      in females. There were racial and gender differences in QoL and beneficial 
      effects on PIH in those patients most at risk. J Drugs Dermatol. 
      2019;18(11):1128-1138.
FAU - Lain, Edward
AU  - Lain E
FAU - Day, Doris
AU  - Day D
FAU - Harper, Julie
AU  - Harper J
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 (Keratolytic Agents)
RN  - 5688UTC01R (Tretinoin)
MH  - Acne Vulgaris/*drug therapy/ethnology/pathology
MH  - Administration, Cutaneous
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Ethnicity
MH  - Female
MH  - Gender Identity
MH  - Humans
MH  - Keratolytic Agents/*administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Quality of Life
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
MH  - Tretinoin/*administration & dosage
MH  - United States
MH  - Young Adult
EDAT- 2019/11/20 06:00
MHDA- 2020/01/31 06:00
CRDT- 2019/11/20 06:00
PHST- 2019/11/20 06:00 [entrez]
PHST- 2019/11/20 06:00 [pubmed]
PHST- 2020/01/31 06:00 [medline]
AID - S1545961619P1128X [pii]
PST - ppublish
SO  - J Drugs Dermatol. 2019 Nov 1;18(11):1128-1138.