title: Efficacy and safety of fluocinolone acetonide, hydroquinone, and tretinoin cream in chinese patients with melasma: a randomized, double-blind, placebo-controlled, multicenter, parallel-group study.
abstract: OBJECTIVE
  This study aimed to determine the efficacy and safety of fluocinolone acetonide, hydroquinone, and tretinoin (FAHT) cream for the treatment of moderate and severe facial melasma. The primary objective was assessment of clinical efficacy, instrumental measured efficacy, and integral therapeutic efficacy at the end of weeks 4 and 8.
  
  
  METHODS
  A total of 233 subjects were randomly allocated (1:1 ratio) to receive topically administered FAHT cream (n = 117) or placebo (n = 116) once nightly for 8 weeks. Observed side effects were documented throughout.
  
  
  RESULTS
  In the per protocol set (PPS; those subjects who met all requirements of the protocol), the integral therapeutic efficacy rate of FAHT cream on moderate and severe melasma was 68.57% (vs. placebo, 0.94%), the clinical effective rate of FAHT cream was 74.29 % (vs. placebo, 0.94%), and the instrumental measure efficacy of FAHT cream was 71.43% (vs. placebo, 6.60%). The difference in efficacy between the two groups was statistically significant (p < 0.001). In the full analysis set (FAS; the PPS and those subjects who were lost to follow-up but received at least one study treatment), the integral therapeutic efficacy rate of FAHT cream was 64.60% (vs. placebo, 0.88%), the clinical effective rate of FAHT cream was 69.91% (vs. placebo, 0.88%), and the instrumental measure efficacy of FAHT cream was 69.03 % (vs. placebo, 7.08%). The difference in efficacy between the two groups was statistically significant (p < 0.001). Of 113 subjects in the FAHT group, 34 (30.1%) reported adverse effects. Most of the pathological adverse effects were mild and resolved with either continuous treatment or discontinuation. Of 113 subjects in the placebo group, three (2.6%) reported mild adverse effects. No severe adverse effects or other abnormal clinical results were associated with the study treatment.
  
  
  CONCLUSIONS
  FAHT cream is efficacious, well tolerated, and has a high margin of safety for the treatment of moderate and severe melasma in the Chinese population.
authors.affiliation: Department of Dermatology, The Third Affiliated Hospital of Sun Yat-sen University, 600 Tianhe Road, Guangzhou, 510630, China, zjsums@163.com.
authors.forename: Zijian
authors.initials: Z
authors.lastname: Gong
authors.forename: Wei
authors.initials: W
authors.lastname: Lai
authors.forename: Guang
authors.initials: G
authors.lastname: Zhao
authors.forename: Xuemin
authors.initials: X
authors.lastname: Wang
authors.forename: Min
authors.initials: M
authors.lastname: Zheng
authors.forename: Li
authors.initials: L
authors.lastname: Li
authors.forename: Qingqi
authors.initials: Q
authors.lastname: Yang
authors.forename: Yuping
authors.initials: Y
authors.lastname: Dang
authors.forename: Lunfei
authors.initials: L
authors.lastname: Liu
authors.forename: Ying
authors.initials: Y
authors.lastname: Zou
mesh_terms: D000293:Adolescent; D000328:Adult; D044466:Asian People; D004311:Double-Blind Method; D005260:Female; D005446:Fluocinolone Acetonide / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D006873:Hydroquinones / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008548:Melanosis / Q000188:drug therapy*; D008875:Middle Aged; D014212:Tretinoin / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
chemical_list: D006873:Hydroquinones; D005446:Fluocinolone Acetonide; D014212:Tretinoin; C031927:hydroquinone