title: A double-blind vehicle-controlled study of a preparation containing undecylenoyl phenylalanine 2% in the treatment of melasma in females.
abstract: BACKGROUND
  Undecylenoyl phenylalanine is a novel skin-lightening agent, probably acting as α-melanocyte-stimulating hormone (α-MSH) and beta-adrenergic receptor (β-ADR) antagonist.
  
  
  OBJECTIVE
  The objective of this double-blind randomized comparative study was to evaluate the efficacy and safety of a preparation containing undecylenoyl phenylalanine 2% in the topical treatment of melasma in females.
  
  
  METHODS
  Forty female patients with melasma were randomly assigned to apply either the active preparation or the vehicle alone, twice daily for 12 weeks. Patients were evaluated monthly for efficacy and safety.
  
  
  RESULTS
  In all, 37 patients completed the study. Of the 20 patients on active treatment, no one responded completely, but 17 (85%) had partial response. Of them, 11 had moderate improvement and six had marked improvement. Lightening of the lesions was evident from the first follow-up visit at 4 weeks. A statistically significant difference (P < 0.001) in efficacy between the active preparation and the vehicle was documented. Using patient assessment ratings, 80% were extremely satisfied or satisfied with the result. The reported side effects were minor and included erythema and itching or burning at the site of application.
  
  
  CONCLUSIONS
  Undecylenoyl phenylalanine 2% achieved a significant lightening of melasma lesions with minimal side effects.
authors.affiliation: Second Department of Dermatology and Venereology, National and Kapodistrian University of Athens Medical School, "Attikon" General University Hospital, Athens, Greece.
authors.forename: Alexander
authors.initials: A
authors.lastname: Katoulis
authors.forename: Antigoni
authors.initials: A
authors.lastname: Alevizou
authors.forename: Efthymia
authors.initials: E
authors.lastname: Soura
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Mantas
authors.forename: Evangelia
authors.initials: E
authors.lastname: Bozi
authors.forename: Stamatis
authors.initials: S
authors.lastname: Gregoriou
authors.forename: Michalis
authors.initials: M
authors.lastname: Makris
authors.forename: Dimitris
authors.initials: D
authors.lastname: Rigopoulos
mesh_terms: D000328:Adult; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004890:Erythema / Q000139:chemically induced; D005260:Female; D006801:Humans; D055666:Lipopeptides / Q000009:adverse effects / Q000627:therapeutic use*; D008548:Melanosis / Q000188:drug therapy*; D008875:Middle Aged; D010146:Pain / Q000139:chemically induced; D017060:Patient Satisfaction; D010649:Phenylalanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011537:Pruritus / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D003879:Dermatologic Agents; D055666:Lipopeptides; C569857:N-undecyl-10-enoylphenylalanine; D010649:Phenylalanine
keywords: melanogenesis; melasma; topical treatment; undecylenoyl phenylalanine; α-melanocyte-stimulating hormone; β-adrenergic receptors