Acyclovir-Penciclovir Cream vs Abreva for Cold Sores

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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

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.12345

Why 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?

CM

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

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.
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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Study Drug (acyclovir-penciclovir cream)Experimental Treatment1 Intervention
Group II: Active Comparator (Abreva)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+

Citations

Acyclovir Cream for Treatment of Herpes Simplex LabialisPenciclovir cream reduced the median time to healing by 0.7 days (13%; P < 0.001) and the median time to loss of pain by 0.6 days (15%; P < 0.001). As in the ...
Efficacy and Safety of Acyclovir-penciclovir Cream Versus ...This will be a randomized, efficacy assessor-blinded, parallel group, pilot study of up to 40 subjects with documented herpes labialis.
Effective treatment of herpes simplex labialis with ...Combined data from two trials revealed that penciclovir recipients lost classical lesions 31 percent faster than did placebo recipients (hazard ratio, or HR, = ...
A Systematic Review on the Efficacy of Topical Acyclovir, ...Effective treatment of herpes simplex labialis with penciclovir cream: Combined results of two trials. J Am Dent Assoc. 2002;133(3):303-9. 33. Habbema L et ...
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/11559210/
Comparison of new topical treatments for herpes labialisResults: Penciclovir cream effected modest reductions in lesion number (19%), area (38%), and virus titer (88%) compared with its vehicle control, and each of ...
Infectious Substances – Herpes simplex virusPROPHYLAXIS: Acyclovir can be used as a prophylactic drug to prevent reactivation of herpes labialis after exposure to ultraviolet radiation, facial surgery, ...
Gainwell Technologies - Therapeutic Class ReviewSafety and effectiveness of acyclovir cream or penciclovir cream in pediatric patients less than 12 years of age have not been established.
Therapeutic Class Overview - Antivirals, TopicalThe safety of acyclovir/hydrocortisone was also demonstrated in adolescents with herpes labialis (Strand et al 2012). Adverse events were ...
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