Topical lipophilic epigallocatechin-3-gallate on herpes labialis: a phase II clinical trial of AverTeaX formula

Oral Surg Oral Med Oral Pathol Oral Radiol. 2015 Dec;120(6):717-24. doi: 10.1016/j.oooo.2015.08.018. Epub 2015 Sep 5.

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.

Study design: 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.

Conclusion: AverTeaX formulation containing lipophilic catechins effectively inhibited herpes simplex labialis infection with clinical significance.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Adult
  • Antioxidants / administration & dosage
  • Antioxidants / therapeutic use*
  • Catechin / administration & dosage
  • Catechin / analogs & derivatives*
  • Catechin / therapeutic use*
  • Double-Blind Method
  • Female
  • Flavonoids / administration & dosage
  • Flavonoids / therapeutic use*
  • Herpes Labialis / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Quality of Life
  • Recurrence
  • Surveys and Questionnaires
  • Tea*
  • Treatment Outcome

Substances

  • Antioxidants
  • AverTeaX
  • Flavonoids
  • Tea
  • Catechin
  • epigallocatechin gallate