Acyclovir-Penciclovir Cream vs Abreva for Cold Sores
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two creams: a new acyclovir-penciclovir cream and an active comparator, Abreva, to determine which is more effective for treating cold sores. It focuses on individuals who have experienced cold sores triggered by sun exposure for at least a year and can recall where their sores typically appear. Participants will maintain a diary to track pain and symptoms over a 10-day period. This trial may suit those who have had HSV-1 breakouts from UV exposure and notice warning signs before an outbreak. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that you stop taking any antiviral medications, steroids, immune suppressants, chemotherapeutic agents, and certain pain relievers like NSAIDs before and during the study. If you are on these medications, you may need to stop them to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that acyclovir and penciclovir creams effectively treat cold sores and are generally well-tolerated. Studies found that penciclovir cream speeds up healing and reduces pain more quickly than using no cream. Acyclovir often prevents cold sores from returning after triggers like sunlight exposure.
However, the safety of acyclovir and penciclovir creams remains unconfirmed for children under 12 years old. Overall, these creams are considered safe for adults and teens with cold sores. Side effects are rare but may include mild skin irritation. Always consult a healthcare provider for personalized advice.12345Why do researchers think this study treatment might be promising for cold sores?
Unlike most treatments for cold sores, which typically rely on single antiviral agents like acyclovir or penciclovir, the acyclovir-penciclovir cream combines both active ingredients. This dual-action formula targets the herpes simplex virus more effectively by using two mechanisms, potentially enhancing the cream's ability to reduce outbreak duration and severity. Researchers are excited because this combination could provide faster relief and improved efficacy compared to standard options like Abreva, which only contains docosanol.
What evidence suggests that this trial's treatments could be effective for cold sores?
Research has shown that acyclovir-penciclovir cream, which participants in this trial may receive, can effectively treat cold sores, also known as herpes labialis. Studies have found that penciclovir cream speeds up the healing of cold sores by about 13% and reduces pain by 15%. One study discovered that penciclovir clears up typical sores 31% faster than if left untreated. These findings suggest that acyclovir-penciclovir cream may help cold sores heal quicker and become less painful. Meanwhile, another group in this trial will use Abreva, an active comparator, to treat cold sores.13678
Who Is on the Research Team?
Christopher M Hull, M.D.
Principal Investigator
University of Utah Dermatology
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 with a history of cold sores from herpes simplex virus, particularly those triggered by UV exposure. Participants must have had at least one outbreak in the past year and typically experience warning signs before an outbreak. They should be able to follow the study's procedures and document their symptoms.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Subjects undergo UV radiation to induce herpes labialis and are assigned study medication
Treatment
Participants apply study medication at the onset of cold sore symptoms and track lesion progression
End of Study
Final assessment of lesion and collection of study materials
Follow-up
Safety follow-up to monitor for any new adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Abreva
- Acyclovir-penciclovir Cream
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor