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

Amy Clewell ND,^a Matt Barnes MS,^aJohn R. Endres ND,^a Mansoor Ahmed PhD,^b Daljit K. S. Ghambeer MD^c

^aAIBMR Life Sciences, Inc., Puyallup, WA ^bSci-chem International Pty Ltd, New South Wales, Australia ^cApothecaries Ltd, New Delhi, India

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 partici-pants 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.

There are many viruses that belong to the herpes family, all of which share some of the same characteristics. For example, most cause blisters, occurring long after exposure, and result in recurring infections. Some viruses affect certain areas of the body while others might occur in almost any area. It is the herpes simplex virus 1 (HSV 1) that causes cold sores.

The HSV 1 virus spreads from person to person during close contact, for example while kissing. You can also get the virus by using an infected person’s toothbrush or by sharing eating utensils. The lesions, sometimes called “fever blisters”, occur on and around the lips. However, it often takes months or years following exposure for the first HSV 1 cold sore to appear. That’s the reason people often wonder “How can you get a cold sore when you haven’t been exposed to the HSV 1 virus?” In fact they have been exposed, and actually encountered the virus long before the first signs of a cold sore occurred. For those who do experience symptoms early on, they may notice the cold sores anywhere from two to twelve days after exposure.

There is no cure for the herpes virus. Once you have it, it stays with you for the rest of your life. The frequency and severity of repeat infections varies among different people. Many people never have symptoms and don’t even know they have the HSV 1 virus in their body. Some people might get one cold sore years apart from the next. Others experience frequent cold sores on their lips and entire mouth. That’s largely due to the different triggers that cause cold sore outbreaks.

Some people only occasionally get cold sore outbreaks while others seem to go from outbreak to outbreak with little time between. You must have the HSV 1 virus to get cold sores, but there are also triggers that lead to outbreaks. The herpes virus “goes into hiding” in your nerve cells, where it is safe from your immune system. Once exposed to certain triggers, the virus “wakes up” and starts replicating and spreading. Normally, the immune system helps fight off invaders like the HSV 1 virus, but the virus’ ability to stay hidden helps it to protect itself.

If you don’t know what brings on cold sores, you won’t know what to avoid and you’re more likely to experience frequent exposure to the triggers. Some common cold sore triggers include:

• Sun exposure
• Stress
• A weakened immune system
• Hormonal changes including taking birth control pills
• Fatigue
• Illness
• Eating certain foods

Avoiding these and other common triggers might help you experience fewer outbreaks. Once you begin to experience the early signs of a cold sore, don’t wait to treat it. Treating a cold sore early might keep the sore from growing larger, and will help it to heal faster.

Many people who get frequent cold sores can feel them coming before it is visible on their skin. These signs might include burning, tingling, or itching. The signs occur several hours prior to the appearance of the cold sore, or up to a day before. This is the best time to apply treatment. Keeping Dynamiclear on hand will ensure you have the treatment ready whenever you need it.

About 80% of all adults are infected with HSV 1 virus, but only about ¼ of them know it. Most become infected at a young age. The herpes virus is highly contagious, making it easy for adults to spread it to children. Children who develop early cold sore symptoms are especially vulnerable as they sometimes develop blisters inside the mouth. Once the fluid-filled blisters become sores, eating becomes painful.

In most children, the virus lies dormant until they are older. Children under the age of twelve years who have a cold sore should see a doctor before treatment is applied at home. If the initial outbreak doesn’t occur until they are twelve or older, they may use the same adult treatment that works for you.

Cold sores aren’t the same for everyone. Some people experience mild symptoms that go virtually unnoticed. For others, having frequent cold sores on lips means pain and other symptoms including:

• Fever
• Swelling of the mouth
• Headaches
• Nausea
• Swollen glands
• Sore throat
• Dehydration

Pregnant women and new parents should be especially vigilant about treating cold sores early and protecting their baby from contact. While cold sores don’t pose any serious risks, there are exceptions. For one, getting a sore on the eye can lead to scarring of the cornea or even blindness. People with compromised immune systems are also at a higher risk of complications from the virus. This includes individuals with certain medical conditions such as HIV/AIDS or those who have undergone cancer chemotherapy.

Herpes can affect the organs in people with a weakened immune system, or spread across larger areas of the body in people with eczema.

Getting a cold sore isn’t fun for anyone. But for some people, it goes beyond discomfort. For those people who have the risk factors listed above, a cold sore can result in a medical emergency. People with cold sores aren’t the only ones affected. You can put those you are closest to at risk of developing a cold sore infection and possible serious side effects.

Prevention is the best approach for keeping cold sore breakouts under control. Keep Dynamiclear handy for those times when you start experiencing early cold sore symptoms. Ideally, you can prevent your cold sore from ever appearing and help protect yourself and everyone you’re close to.

The second stage usually starts one or two days after the first stage has begun. This is when the blister(s) first appear on your skin, and the area around and under the blisters will begin to appear red.

You can still apply cold sore treatment after blisters appear or during any of the more advanced stages, but it is best to start the treatment as early as possible. Early treatment helps to eliminate any cold sore swelling and pain that accompanies the blisters. Different people experience different levels of discomfort from cold sore blisters. Those with one cold sore might have minimal discomfort. Someone with 2 or 3 cold sores at once will probably have more pain, not to mention more embarrassment due to the increased visibility of the symptoms.

It is important to stay hydrated during the second stage. Increase your water intake and take measures to prevent the spread of the herpes virus. Always wash your hands with warm, soapy water after handling the area. Also, avoid citrus, salty, and spicy foods, and hot liquids that might add to your discomfort.

Cold sores are highly contagious. Remember that any contact you have with another person can easily transit the virus to them.

A few days after the blisters appear, the cold sore breaks open and the fluid will run out. The blisters turn into flat, red lesions that are painful. When the fluid is weeping from the sores, they are at their most contagious. Avoid touching the area and don’t pick at the sores. The infection might spread or you may develop a secondary bacterial skin infection.

Once the weeping stage ends, the blister begins to dry and crust over. During the crusting stage, the blisters will turn from red to yellow or brown.

Finally, the lesions begin to heal. They scab over and begin flaking away until they gradually disappear.

Herpes viruses spread from skin to skin contact. It’s also possible to get the HSV 1 virus that causes cold sores from by an infected person’s toothbrush, eating utensils, or other personal items. The lips and mouth are often the point of contact at which the person acquires the virus, and it can also be transmitted via your saliva, even if you never experience any symptoms from it. As a result, it is more likely to cause an outbreak in and around your mouth and lips. Also, in the winter when you get dry, chapped lips, a cold sore outbreak is more likely.

The name of “cold sores” gives us the wrong impression about what causes the blisters to develop. They don’t have anything to do with colds. The herpes virus that causes cold sores is not only common in this country, but in countries around the world. Nearly every adult will have at least one cold sore during their lifetime. The virus becomes dormant soon after it enters the body, often going unnoticed for long periods of time. It isn’t until something triggers the virus and “wakes it up” that an infection begins.
Even if you’ve never experienced a cold sore before, you might have an initial outbreak during a time of stress, an illness or injury, or even extensive sun exposure. If you are one of the unlucky people who experiences frequent, severe cold sore outbreaks, this is probably due to exposure to your triggers.
To help get recurrent episodes under control, use an effective cold sore treatment at the first signs of a cold sore. Keep a notebook and write down everything you do and what you eat. This will help you identify your triggers so that you can avoid the cause of your outbreaks. Once you have the herpes virus, there is no cure to get rid of it. But taking the right precautions can help reduce the risk of complications, and keep you from spreading the germ to other areas of your skin or to other people.

When you use Dynamiclear cold sore treatment, you can make your cold sore gone in 2 days! The treatment stops transmission, reduces healing time, and works during any of the cold sore stages. It also has antifungal and anti-bacterial properties that prevent the risk of secondary infections. There’s even a pain reliever to help you deal with the discomfort caused by cold sore breakouts.
The HSV 1 virus that causes cold sores can’t be cured; but it can be treated so that you have more control over your pain, swelling, and the appearance of cold sore lesions. Make sure you have cold sore treatment on hand for the next time a cold sore makes an appearance.