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New cold sore cream shows promise in small study

NCT ID NCT06558838

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a cream containing acyclovir and penciclovir against an over-the-counter cream (Abreva) for preventing cold sores caused by UV light. Forty adults with a history of cold sores were exposed to UV light to trigger an outbreak, then treated with one of the creams. Researchers tracked whether the cold sore progressed to a blister and how quickly it healed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
acyclovir-penciclovir cream
What this could lead to
If it works, this could point toward a more effective cream for preventing cold sores from forming after sun exposure.
What could go wrong
This is a small, early pilot study with only 40 people, so results may not apply to everyone. The cream may not work better than the existing treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

40 people

The number who actually took part.

Started

Aug 2024

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Understands the requirements of the study and provides written informed consent prior to undergoing any study-related procedures. * Subject is a male or female between the ages of 18-80 years old, inclusive. * Fitzpatrick skin type II or III. * History of at least one year of herpes labialis induced by UV exposure. * Able to recall exact location of most common or most recent outbreak. * History of at least 50% of cold sore outbreaks occurring with UV (sun) exposure. * At least 1 HSV-1 outbreak within the past 12 months. * Experiences prodromal symptoms before HSV-1 outbreaks. * Subject is willing and able to comply with protocol-specified dosing, visits to the clinic and tracking of pain. Exclusion Criteria: * Outbreak \<2 weeks prior to enrollment. * History of herpes simplex vaccine. * On antiviral suppression within the past 30 days. * Requires more than acetaminophen for pain from recurrent HSV outbreaks. * On any systemic or topical steroid, immune suppressant or chemotherapeutic agent within the past 14 days. * Use of tanning beds, history of sunburn, or beach vacation \<2 weeks prior to enrollment. * History of photosensitivity, lupus erythematosus, or current use of a highly photosensitizing medication in the opinion of the investigator. * Current immunosuppressed state due to underlying disease (i.e. HIV infection) concomitant treatment (i.e. chemotherapy). * Current upper respiratory tract infection or any active illness that could trigger cold sores or affect overall health of the patient or the assessment of the study agent. * Pregnant or intending to become pregnant during the study. * Abnormal skin conditions in the area of the recurrent HSV1 outbreaks. * Enrolled in another clinical trial within the past 30 days. * On any analgesics or NSAIDs that cannot be stopped during the study. * Alcohol or drug abuse.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Utah MidValley Dermatology

    Murray, Utah, 84107, United States

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