title: Preventing melasma recurrence: prescribing a maintenance regimen with an effective triple combination cream based on long-standing clinical severity.
abstract: BACKGROUND
  The relapsing nature of melasma emphasizes the need to maintain efficacy achieved after acute treatment.
  
  
  OBJECTIVE
  To compare clinical efficacy and safety of two 6-month Triple Combination (TC; containing fluocinolone acetonide, hydroquinone and tretinoin) maintenance regimens in subjects with moderate to severe melasma, after daily treatment up to 8 weeks.
  
  
  METHODS
  This randomized, investigator-blinded, controlled study had a maintenance phase of 6 months. Sixteen centres in Brazil and Mexico enrolled 242 subjects 18 years or older attaining no or mild melasma after 8 weeks of daily TC applications. Subjects were randomized to receive TC in a twice weekly or tapering regimen [3/week (1st month), 2/week (2nd month), 1/week (4th month)]. Efficacy and safety measurements included median time to relapse and relapse-free rate, Global Severity Score, Melasma Area and Severity Index score (MASI), subject's assessment, quality of life questionnaire (MelasQol), and adverse events.
  
  
  RESULTS
  The majority (78.8%) had no or mild melasma (GSS ≤ 1) at week 8 and entered maintenance phase. After 6 months, 53% of patients remained relapse-free with improved quality of life, and time to relapse was similar between groups (about 190 days). Melasma severity at study entry, not maintenance baseline, influenced relapse rate. The twice weekly regimen tended to show better effectiveness in postponing relapse in severe melasma. Both regimens were safe.
  
  
  CONCLUSIONS
  After resolution of melasma with TC, maintenance therapy over 6 months was successful in preventing relapse in over half of the patients who entered maintenance phase. Prescribing medicines should be adapted to patients based on melasma severity.
authors.affiliation: Hospital General de México O.P.D., Mexico. mariare1@yahoo.com
authors.forename: I
authors.initials: I
authors.lastname: Arellano
authors.forename: T
authors.initials: T
authors.lastname: Cestari
authors.forename: J
authors.initials: J
authors.lastname: Ocampo-Candiani
authors.forename: L
authors.initials: L
authors.lastname: Azulay-Abulafia
authors.forename: P
authors.initials: P
authors.lastname: Bezerra Trindade Neto
authors.forename: D
authors.initials: D
authors.lastname: Hexsel
authors.forename: J
authors.initials: J
authors.lastname: Machado-Pinto
authors.forename: H
authors.initials: H
authors.lastname: Muñoz
authors.forename: M C
authors.initials: MC
authors.lastname: Rivitti-Machado
authors.forename: J A
authors.initials: JA
authors.lastname: Sittart
authors.forename: A R
authors.initials: AR
authors.lastname: Trindade de Almeida
authors.forename: V
authors.initials: V
authors.lastname: Rego
authors.forename: F
authors.initials: F
authors.lastname: Paliargues
authors.forename: K
authors.initials: K
authors.lastname: Marques-Hassun
mesh_terms: D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005446:Fluocinolone Acetonide / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D006873:Hydroquinones / Q000008:administration & dosage / Q000627:therapeutic use; D008548:Melanosis / Q000188:drug therapy / Q000473:pathology / Q000517:prevention & control*; D011788:Quality of Life; D012008:Recurrence; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D014212:Tretinoin / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D003879:Dermatologic Agents; D006873:Hydroquinones; D005446:Fluocinolone Acetonide; D014212:Tretinoin; C031927:hydroquinone