title: Topical lipophilic epigallocatechin-3-gallate on herpes labialis: a phase II clinical trial of AverTeaX formula.
abstract: OBJECTIVE
  Previous in vitro and in vivo studies indicated that catechins from the tea plant (Camellia sinensis) have a therapeutic effect on herpes simplex virus infections. The aim of this study was to clinically evaluate a topical proprietary formulation containing lipophilic catechins (AverTeaX, Camellix, LLC, Evans, GA, USA) on recurrent herpes labialis.
  
  
  METHODS
  A double-blind, placebo-controlled, randomized trial with 40 participants, initially in two groups.
  
  
  RESULTS
  Compared with the vehicle (100% glycerin USP, CVS Pharmacies, Inc., Woonsocket, RI, USA) group, AverTeaX applied topically six to eight times daily resulted in a significant reduction in clinical episode duration (median 4.5 days vs. 9 days; P = .003) and shortened blistering and ulceration stages within an episode from a median of 3 days to 1 day (P = .0003). Median quality-of-life scores, based on a multiquestion survey, showed significant differences between the groups with respect to duration of itching, from a median of 4 days to 1 day (P = .0021), and duration until symptom free, from a median of 8 days to 4 days (P = .0016). Significant differences were not found for median scores for itching, pain, burning, swelling, bleeding, and stress. Adverse effects were not reported.
  
  
  CONCLUSIONS
  AverTeaX formulation containing lipophilic catechins effectively inhibited herpes simplex labialis infection with clinical significance.
authors.affiliation: Department of General Dentistry, School of Stomatology Hospital, Zhejiang University, Hangzhou, China.
authors.forename: Man
authors.initials: M
authors.lastname: Zhao
authors.affiliation: Department of General Dentistry, School of Stomatology Hospital, Zhejiang University, Hangzhou, China.
authors.forename: Rong
authors.initials: R
authors.lastname: Zheng
authors.affiliation: Department of General Dentistry, School of Stomatology Hospital, Zhejiang University, Hangzhou, China.
authors.forename: Jinyan
authors.initials: J
authors.lastname: Jiang
authors.affiliation: Camellix, LLC, Augusta, GA, USA; Current association: DENTAC, US Army, Fort Gordon, GA, USA.
authors.forename: Douglas
authors.initials: D
authors.lastname: Dickinson
authors.affiliation: Department of General Dentistry, School of Stomatology Hospital, Zhejiang University, Hangzhou, China.
authors.forename: Baiping
authors.initials: B
authors.lastname: Fu
authors.affiliation: Department of Biological Science, Seton Hall University, South Orange, NJ, USA.
authors.forename: Tin-Chun
authors.initials: TC
authors.lastname: Chu
authors.affiliation: Department of Biology and Molecular Biology, Montclair State University, Montclair, NJ, USA.
authors.forename: Lee Hwang
authors.initials: LH
authors.lastname: Lee
authors.affiliation: Skin and Cancer Center of Arizona, Chabdker, AZ, USA.
authors.forename: Henna
authors.initials: H
authors.lastname: Pearl
authors.affiliation: Department of Oral Biology, Department of Oral Health & Diagnostic Sciences, College of Dental Medicine, Georgia Regents University, Augusta, GA, USA. Electronic address: shsu@gru.edu.
authors.forename: Stephen
authors.initials: S
authors.lastname: Hsu
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000975:Antioxidants / Q000008:administration & dosage / Q000627:therapeutic use*; D002392:Catechin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005419:Flavonoids / Q000008:administration & dosage / Q000627:therapeutic use*; D006560:Herpes Labialis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012008:Recurrence; D011795:Surveys and Questionnaires; D013662:Tea; D016896:Treatment Outcome
chemical_list: D000975:Antioxidants; C000611562:AverTeaX; D005419:Flavonoids; D013662:Tea; D002392:Catechin; C045651:epigallocatechin gallate