Study comparing aciclovir gel and cream effectiveness in treating recurrent cold sores (herpes labialis)

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What is this study about?

This study examines treatments for Recurrent Herpes Labialis, commonly known as cold sores – a condition that causes recurring outbreaks of blisters and sores around the lips. The study compares two medications containing the antiviral substance aciclovir: Lipovir gel and Zovirax cream, along with a placebo.

The purpose is to determine if Lipovir gel works as effectively as Zovirax cream in treating cold sores. Both medications contain the same amount of active ingredient (5% aciclovir) but come in different forms – one as a gel and the other as a cream. The medications are applied directly to the skin where cold sores appear.

During the study, participants who experience a cold sore outbreak will apply their assigned treatment to the affected area. They will use the medication for up to 10 days and keep track of how their cold sore heals. The main focus will be on how long it takes for the cold sore to heal completely, from the time treatment begins until the skin returns to normal or symptoms stop.

1 Initial evaluation

Your participation begins when you experience early signs (called prodromal symptoms) of a cold sore outbreak, such as itching, redness, burning, tingling, or irritation in the lip area.

You will be randomly assigned to receive one of three treatments: Lipovir Gel, Zovirax Cream, or a placebo (inactive treatment).

All treatments contain 5% aciclovir, except for the placebo

2 Treatment application

You will need to apply the assigned treatment to the affected area on your lips when you notice the first signs of a cold sore outbreak

The medication should be applied directly to the skin of the affected area

You will receive specific instructions on how often to apply the treatment and for how long to continue using it

3 Daily monitoring

You will need to keep a daily record in a study diary

Record any changes in your symptoms and cold sore appearance

Note any side effects or skin reactions you may experience

Document the time when the cold sore completely heals (when the scab falls off and only light redness may remain)

4 Assessment of results

A healthcare provider will evaluate how long it takes for your cold sore to heal completely

You will be asked to rate how well you tolerated the treatment

You will provide feedback on how acceptable the treatment was to use

Any side effects that occurred during the treatment period will be documented

Who Can Join the Study?

  • Must have experienced at least 3 episodes of cold sores (herpes labialis) in the past year
  • At least half of these cold sore outbreaks must be preceded by early warning signs (prodromal symptoms) such as:
    • Itching
    • Redness
    • Burning
    • Tingling
    • Sense of irritation
  • At least half of these early warning signs must lead to typical cold sore symptoms such as:
    • Ulcers
    • Fluid-filled blisters
    • Hard crusts
  • Must be 18 years or older when signing the consent form
  • Must be able to read, understand, and sign the informed consent document
  • Must be able to understand and follow study procedures, including completing a daily diary

Who Cannot Join the Study?

  • History of allergic reactions to acyclovir (active ingredient in Zovirax) or similar medications
  • Pregnancy or breastfeeding
  • Current participation in other clinical trials
  • Use of antiviral medications in the past 14 days
  • Presence of other skin conditions in the area affected by cold sores
  • Weakened immune system due to medications or medical conditions
  • History of severe or frequent herpes outbreaks requiring constant medication
  • Any serious medical condition that could interfere with study participation
  • Unable to follow study procedures or attend follow-up visits
  • Known sensitivity to any ingredients in the study medications
  • Active cold sore that has been present for more than 48 hours
  • Use of topical treatments on the affected area in the past 24 hours

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Specderm Poznanska Sp. j. Bialystok Poland
One Day Med Sp. z o.o. Szczecin Poland
Synexus Polska Sp. z o.o. Poznan Poland
Ctitnln Mllpawcg Muxgosyrik dc Anns Slnnrquc Katowice Poland
Pieulia Sja z odiy Katowice Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Recruiting
12.06.2024

Trial locations

Investigated drugs:

Lipovir Gel (containing acyclovir) is a topical medication used to treat cold sores caused by herpes labialis. It works by stopping the growth of the herpes virus, helping to reduce the duration and severity of cold sore outbreaks.

Zovirax Cream (containing acyclovir) is a well-established topical antiviral medication used to treat cold sores. It helps speed up healing and reduces the symptoms of herpes labialis outbreaks by preventing the virus from multiplying.

Both medications contain the same active ingredient (acyclovir) but are manufactured by different companies and have different formulations – one as a gel and one as a cream.

Recurrent Herpes Labialis – A common viral infection that causes cold sores or fever blisters, primarily on or around the lips. The condition is caused by the herpes simplex virus type 1 (HSV-1) and is characterized by recurring episodes of fluid-filled blisters. The infection typically begins with tingling or burning sensation, followed by the formation of small blisters that eventually break, form a crust, and heal. Episodes can be triggered by factors such as stress, sunlight exposure, fever, or hormonal changes. The virus remains dormant in nerve cells between outbreaks and can reactivate periodically.

Trial ID:
2023-510338-10-00
Protocol code:
OP-LIPC02
Trial Phase:
Therapeutic confirmatory (Phase III)

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