Topical lipophilic epigallocatechin-3-gallate on herpes labialis

A phase II clinical trial of AverTeaX formula

Man Zhao, Rong Zheng, Jinyan Jiang, Douglas Dickinson, Baiping Fu, Tin Chun Chu, Lee Lee, Henna Pearl, Stephen Hsu

Research output: Contribution to journalArticleResearchpeer-review

7 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)717-724
Number of pages8
JournalOral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
Volume120
Issue number6
DOIs
StatePublished - 1 Dec 2015

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Herpes Labialis
Phase II Clinical Trials
Catechin
Pruritus
Camellia sinensis
Herpes Simplex
Pharmacies
Therapeutic Uses
Tea
Virus Diseases
Simplexvirus
Glycerol
Randomized Controlled Trials
Placebos
Quality of Life
Hemorrhage
Pain
Infection
epigallocatechin gallate
AverTeaX

Cite this

Zhao, Man ; Zheng, Rong ; Jiang, Jinyan ; Dickinson, Douglas ; Fu, Baiping ; Chu, Tin Chun ; Lee, Lee ; Pearl, Henna ; Hsu, Stephen. / Topical lipophilic epigallocatechin-3-gallate on herpes labialis : A phase II clinical trial of AverTeaX formula. In: Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology. 2015 ; Vol. 120, No. 6. pp. 717-724.
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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. 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.",
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Topical lipophilic epigallocatechin-3-gallate on herpes labialis : A phase II clinical trial of AverTeaX formula. / Zhao, Man; Zheng, Rong; Jiang, Jinyan; Dickinson, Douglas; Fu, Baiping; Chu, Tin Chun; Lee, Lee; Pearl, Henna; Hsu, Stephen.

In: Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, Vol. 120, No. 6, 01.12.2015, p. 717-724.

Research output: Contribution to journalArticleResearchpeer-review

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T2 - A phase II clinical trial of AverTeaX formula

AU - Zhao, Man

AU - Zheng, Rong

AU - Jiang, Jinyan

AU - Dickinson, Douglas

AU - Fu, Baiping

AU - Chu, Tin Chun

AU - Lee, Lee

AU - Pearl, Henna

AU - Hsu, Stephen

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N2 - 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.

AB - 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.

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JF - Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology

SN - 2212-4403

IS - 6

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