title: Efficacy and tolerability of oral lactoferrin supplementation in mild to moderate acne vulgaris: an exploratory study.
abstract: OBJECTIVE
  Lactoferrin, an innate defense iron-binding protein, possesses antimicrobial and anti-inflammatory activities. Beneficial systemic effects on inflammatory diseases have been proposed. The aim of the present study was to explore the efficacy and tolerability of oral bovine lactoferrin supplementation in subjects with mild to moderate facial acne vulgaris.
  
  
  METHODS
  In this open-label, single-arm study, 43 adolescents and young adults were enrolled to take a chewable tablet formulation of bovine lactoferrin twice daily for 8 weeks. The primary efficacy endpoint was the improvement in acne lesion counts compared with baseline. Tolerability was evaluated on the basis of adverse event frequencies.
  
  
  RESULTS
  Thirty-nine subjects, aged 17.5 ± 3.8 years, completed the study per protocol. At the end of the study (week 8), a mean reduction in inflammatory lesion count of 20.2% (-2.2 ± 7.0, p = 0.054), in non-inflammatory lesion count of 23.5% (-6.2 ± 9.8, p < 0.001), and in total lesion count of 22.5% (-8.4 ± 13.1, p < 0.001) was observed as compared with baseline. At study conclusion, 76.9% (30 of 39) of subjects showed a reduction in total lesion count. The results for inflammatory acne lesions were variable over the study course. None of the subjects experienced a lactoferrin-related adverse event during the trial.
  
  
  CONCLUSIONS
  Despite the limitations of an uncontrolled, open-label study, the results from this study indicate that lactoferrin in mild to moderate acne vulgaris is well tolerated and may lead to an overall improvement in acne lesion counts in the majority of affected adolescents and young adults when administered as a dietary supplement on a twice daily regimen. Further randomized, placebo-controlled trials of longer duration appear warranted.
authors.affiliation: Institute for Clinical Pharmacology, Medical Faculty, Technical University, Dresden, Germany. edgar.mueller@tu-dresden.de
authors.forename: Edgar A
authors.initials: EA
authors.lastname: Mueller
authors.forename: Sonja
authors.initials: S
authors.lastname: Trapp
authors.forename: Adrian
authors.initials: A
authors.lastname: Frentzel
authors.forename: Wilhelm
authors.initials: W
authors.lastname: Kirch
authors.forename: Victor
authors.initials: V
authors.lastname: Brantl
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy* / Q000473:pathology; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D015415:Biomarkers / Q000032:analysis; D019587:Dietary Supplements; D005260:Female; D006801:Humans; D007781:Lactoferrin / Q000008:administration & dosage* / Q000009:adverse effects*; D008297:Male; D010865:Pilot Projects; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D015415:Biomarkers; D007781:Lactoferrin