Efficacy and Tolerability Assessment of a Topical Formulation Containing Copper Sulfate and Hypericum perforatum on Patients With Herpes Skin Lesions: A Comparative, Randomized Controlled Trial
February 2012 | Volume 11 | Issue 2 | Original Article | 209 | Copyright © February 2012
Amy Clewell ND,a Matt Barnes MS,aJohn R. Endres ND,a Mansoor Ahmed PhD,b Daljit K. S. Ghambeer MDc
aAIBMR Life Sciences, Inc., Puyallup, WA bSci-chem International Pty Ltd, New South Wales, Australia cApothecaries Ltd, New Delhi, India
Abstract
Background: Topical Acyclovir has moderate efficacy on recurrent HSV symptoms, requiring repeat applications for several days. Topical Dynamiclear, which requires only a single dose application, may provide a more effective and convenient treatment option for symptomatic management of HSV.
Objectives: The study assessed the comparative efficacy and tolerability of a single use, topical formulation containing copper sulfate pentahydrate and Hypericum perforatum that is marketed as Dynamiclear™ to a topical 5% Acyclovir cream standard preparation and use.
Methods: A prospective, randomized, multi-centered, comparative, open-label clinical study was conducted. A total of 149 participants between 18 and 55 years of age with active HSV-1 and HSV-2 lesions were recruited for the 14-day clinical trial. Participants were randomized into two groups: A (n=61), those receiving the Dynamiclear formulation, and B (n=59), those receiving 5% Acyclovir. Efficacy parameters were assessed via physical examination at baseline (day 1), day 2, 3, 8, and 14. Laboratory safety tests were conducted at baseline and on day 14.
Results: Use of the Dynamiclear formulation was found to have no significant adverse effects and was well tolerated by participants. All hematological and biochemical markers were within normal range for the Dynamiclear group. Statistically, odds for being affected by burning and stinging sensation were 1.9 times greater in the Acyclovir group in comparison to the Dynamiclear group. Similarly, the odds of being affected by symptoms of acute pain, erythema and vesiculation were 1.8, 2.4, and 4.4 times higher in the Acyclovir group in comparison to the Dynamiclear group.
Conclusions: The Dynamiclear formulation was well tolerated, and efficacy was demonstrated in a number of measured parameters, which are helpful in the symptomatic management of HSV-1 and HSV-2 lesions in adult patients. Remarkably, the effects seen from this product came from a single application.
J Drugs Dermatol. 2012;11(2):209-215.
INTRODUCTION
Herpes simplex virus (HSV) is one of the most common
viral diseases in humans. HSV exists as two types, Herpes simplex virus 1 (HSV-1) and Herpes simplex virus 2 (HSV-2), both distinguished by clinical manifestations,
biological and serological criteria.1 Their characteristic
feature is a capacity to establish latency in the host after the initial infection and to reactivate periodically. Major symptoms
of active infection include prodromal numbness and tingling
around the affected area, induration, erythema, itching, burning, pain in the area, and ulcerated lesions.2,3 In the U.S., over 70-90 percent of adults have the antibody to HSV-1 and approximately 22 percent have the antibody to HSV-2. HSV is the fastest growing infectious disease in the world with 500,000 new cases reported each year. HSV active infections are also associated with enhanced Human Immunodeficiency Virus (HIV) transmission.4-6
Oral and topical Acyclovir preparations are used as the current standard of care for treatment of HSV symptoms, including skin lesions. Acyclovir inhibits the replication of herpes virus via inhibition of the viral DNA polymerase, thus preventing the formation of the DNA replication complex and the elongation
