Acyclovir-Penciclovir Cream vs Abreva for Cold Sores
Trial Summary
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.
What data supports the effectiveness of the drug Acyclovir-Penciclovir Cream for cold sores?
Is Acyclovir-Penciclovir Cream safe for treating cold sores?
How does the drug Acyclovir-Penciclovir Cream differ from other treatments for cold sores?
Acyclovir-Penciclovir Cream combines two antiviral drugs, acyclovir and penciclovir, which may offer a unique approach by potentially enhancing the effectiveness against cold sores compared to using each drug alone. Penciclovir has shown to be more effective than acyclovir in some studies, particularly in reducing the spread of infection and the duration of symptoms.13568
What is the purpose of this trial?
This will be a randomized, efficacy assessor-blinded, parallel group, pilot study of up to 40 subjects with documented herpes labialis. Patients will be treated with the study drug, acyclovir-penciclovir cream, or the active comparator of Abreva.Potential subjects will be assessed during a screening visit that must take place no greater than 2 weeks prior to the Day 1 (Baseline) visit. During the screening period, subjects that meet all other entry criteria will undergo Ultraviolet susceptibility testing to determine the subject's individual minimal erythema dose (MED). Ultraviolet susceptibility testing takes place over two days with exposure to Ultraviolet light on specified regions on the subject's back followed by an assessment of the exposed areas 24 hours later to identify the MED. Subjects who have a measurable MED will be allowed to enroll in the study. Each subject will be randomly assigned in a 1:1 ratio to receive either acyclovir-penciclovir cream or Comparator (Abreva).Patients who express a cold sore will track the lesion with a diary card to rate their pain levels, and any unusual symptoms at Day 1, Day 3, Day 5, Day 7, and Day 10. Patients may also take photographs of the lesion throughout the study.
Research Team
Christopher M Hull, M.D.
Principal Investigator
University of Utah Dermatology
Eligibility Criteria
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
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
Treatment Details
Interventions
- Abreva
- Acyclovir-penciclovir Cream
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor