title: A randomized, double-blind, placebo-controlled trial to determine the efficacy and safety of lactoferrin with vitamin E and zinc as an oral therapy for mild to moderate acne vulgaris.
abstract: Lactoferrin is an iron-binding milk-derived protein that has shown antibacterial and anti-inflammatory effects in vitro and in vivo. The objective of this study was to determine the efficacy and safety of lactoferrin, combined with vitamin E and zinc, for mild to moderate acne vulgaris. In this randomized, double-blind, placebo-controlled trial, 168 subjects aged 13-40 years old were randomly assigned to take either a capsule formulation containing lactoferrin with vitamin E and zinc or placebo twice a day for 3 months. The primary outcome measure was a reduction in the number of acne lesions compared to placebo. A total of 164 subjects completed the study per protocol. The lactoferrin group (n = 82) showed a significant median percent reduction in total lesions as early as 2 weeks (14.5%, P = 0.0120), with the maximum reduction occurring at week 10 (28.5%, P < 0.0001) compared to placebo group (n = 82). Maximum reduction in comedones (32.5%, P < 0.0001) and inflammatory lesions (44%, P < 0.0001) was also seen at week 10 compared to placebo. Sebum scores were improved by week 12. No adverse events were observed during the trial. A twice daily regimen of lactoferrin with vitamin E and zinc significantly reduced acne lesions in people with mild to moderate acne vulgaris.
authors.affiliation: Clinical Trial Management and Testing Associates, Inc., Alabang, Muntinlupa City, Philippines.
authors.forename: Heidi
authors.initials: H
authors.lastname: Chan
authors.affiliation: Clinical Trial Management and Testing Associates, Inc., Alabang, Muntinlupa City, Philippines.
authors.forename: Gertrude
authors.initials: G
authors.lastname: Chan
authors.affiliation: Research and Development Division, United Laboratories, Inc., Mandaluyong City, Philippines.
authors.forename: Joyce
authors.initials: J
authors.lastname: Santos
authors.affiliation: Research and Development Division, United Laboratories, Inc., Mandaluyong City, Philippines.
authors.forename: Kennie
authors.initials: K
authors.lastname: Dee
authors.affiliation: Research and Development Division, United Laboratories, Inc., Mandaluyong City, Philippines.
authors.forename: Juliene Kimberly
authors.initials: JK
authors.lastname: Co
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000975:Antioxidants / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D006801:Humans; D007781:Lactoferrin / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D012720:Severity of Illness Index; D012737:Sex Factors; D014810:Vitamin E / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult; D015032:Zinc / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000890:Anti-Infective Agents; D000975:Antioxidants; D014810:Vitamin E; D007781:Lactoferrin; D015032:Zinc