Man Zhao1, Rong Zheng1, Jinyan Jiang1, Douglas Dickinson2, Baiping Fu1, Tin-Chun Chu3, Lee Hwang Lee4, Henna Pearl5, Stephen Hsu6. 1. Department of General Dentistry, School of Stomatology Hospital, Zhejiang University, Hangzhou, China. 2. Camellix, LLC, Augusta, GA, USA; Current association: DENTAC, US Army, Fort Gordon, GA, USA. 3. Department of Biological Science, Seton Hall University, South Orange, NJ, USA. 4. Department of Biology and Molecular Biology, Montclair State University, Montclair, NJ, USA. 5. Skin and Cancer Center of Arizona, Chabdker, AZ, USA. 6. 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.
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.
RCT Entities:
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.