40 Participants Needed

Acyclovir-Penciclovir Cream vs Abreva for Cold Sores

AA
AD
Overseen ByAdrianne D Evans, CCRC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Research shows that penciclovir cream can reduce the duration of cold sore lesions and associated pain by a few hours, although it may not prevent the appearance of skin lesions. Penciclovir has been found to be more effective than acyclovir in treating cold sores.12345

Is Acyclovir-Penciclovir Cream safe for treating cold sores?

The safety of penciclovir and acyclovir creams has been evaluated in studies for treating cold sores, and they are generally well-tolerated by patients. No specific safety concerns were highlighted in the studies, indicating they are safe for use in humans.12367

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

CM

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

I understand the study's requirements and have given my written consent.
My skin type is either fair or light brown.
Half of my cold sore outbreaks happen after sun exposure.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Induction

Subjects undergo UV radiation to induce herpes labialis and are assigned study medication

1 day
1 visit (in-person)

Treatment

Participants apply study medication at the onset of cold sore symptoms and track lesion progression

7-10 days
4 visits (in-person or virtual)

End of Study

Final assessment of lesion and collection of study materials

1 day
1 visit (in-person)

Follow-up

Safety follow-up to monitor for any new adverse events

2 days
1 phone call

Treatment Details

Interventions

  • Abreva
  • Acyclovir-penciclovir Cream
Trial Overview The study compares acyclovir-penciclovir cream with Abreva in treating cold sores caused by herpes. Up to 40 subjects will be randomly assigned to either treatment and will use diaries and photos to track their pain levels and any unusual symptoms over a period of up to 10 days.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Study Drug (acyclovir-penciclovir cream)Experimental Treatment1 Intervention
Patients will treat herpes simplex eruption with active study drug.
Group II: Active Comparator (Abreva)Active Control1 Intervention
Patients will treat herpes simplex eruption with Abreva.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+

References

Recurrent herpes labialis: efficacy of topical therapy with penciclovir compared with acyclovir (aciclovir). [2020]
Penciclovir cream for the treatment of herpes simplex labialis. A randomized, multicenter, double-blind, placebo-controlled trial. Topical Penciclovir Collaborative Study Group. [2022]
Penciclovir: new preparation. Slightly effective. [2013]
Herpes labialis treatment with acyclovir 5% modified aqueous cream: a double-blind randomized trial. [2022]
A comparison of topical application of penciclovir 1% cream with acyclovir 3% cream for treatment of genital herpes: a randomized, double-blind, multicentre trial. [2020]
Evaluation of the in vitro skin permeation of antiviral drugs from penciclovir 1% cream and acyclovir 5% cream used to treat herpes simplex virus infection. [2021]
Herpes labialis in skiers: randomized clinical trial of acyclovir cream versus placebo. [2019]
Inhibitory action of acyclovir (ACV) and penciclovir (PCV) on plaque formation and partial cross-resistance of ACV-resistant varicella-zoster virus to PCV. [2020]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security