title: Safety and efficacy of a novel multimodality hydroquinone-free skin brightener over six months.
abstract: BACKGROUND
  Abnormal accumulation of melanin is a common aesthetic skin concern. For years, the gold standard for the treatment of hyperpigmentary disorders has been 4% hydroquinone (HQ). Due to regulatory agencies around the world questioning the safety of HQ, there has been interest in developing new HQ-free skin brightening/lightening products. A multimodality product (skin brightening complex) addressing various pathways for melanogenesis was developed as an alternative to HQ.
  
  
  OBJECTIVE
  The skin brightening complex was studied for efficacy and tolerability in subjects with moderate to severe facial hyperpigmentation.
  
  
  METHODS
  Subjects were instructed to apply skin brightening complex to the entire face twice daily and to follow a standard skin care regimen (facial cleanser, moisturizer, and sunscreen) during the course of the study. The study was conducted over a 12-week period and consisted of evaluation visits at baseline and at weeks 4, 8, and 12. At each visit, subjects were evaluated by an investigator for clinical efficacy and tolerability using grading scales. Standardized digital photographs and spectrophotometric assessments were also taken. Self-assessment questionnaires were completed at weeks 4, 8, and 12. To assess longer-term safety and efficacy, 10 subjects elected to continue treatment for an additional 12 weeks (24 weeks total), with evaluations at weeks 18 and 24.
  
  
  RESULTS
  Twenty-six subjects completed the 12-week study, and 8 subjects completed treatment for an additional 12 weeks (24 weeks in total). In the 12-week study, the skin brightening complex was shown to be effective and significantly improved Overall Hyperpigmentation at weeks 4, 8, and 12 compared with baseline. The skin brightening complex also significantly improved the Mottled Pigmentation Area and Severity Index ([MoPASI], a modified Melasma Area and Severity Index [MASI] scale) at weeks 8 and 12 compared with baseline. These efficacy benefits continued at 24 weeks. The product was well tolerated at all evaluation visits. Subject questionnaires showed 80% or more of the subjects reporting pigmentation improvement and satisfaction with the skin brightening complex at all evaluation visits.
  
  
  CONCLUSIONS
  This HQ-free skin brightening complex was effective and well tolerated in subjects with facial hyperpigmentation who were treated for as long as 24 weeks.
authors.affiliation: The Center for Skin Research, Houston, TX, USA. sbruce@sba-skincare.com
authors.forename: Suzanne
authors.initials: S
authors.lastname: Bruce
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017495:Hyperpigmentation / Q000188:drug therapy*; D008297:Male; D008543:Melanins / Q000378:metabolism*; D008875:Middle Aged; D017060:Patient Satisfaction; D012720:Severity of Illness Index; D012880:Skin Pigmentation / Q000187:drug effects*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D003879:Dermatologic Agents; D008543:Melanins