Recurrent Herpes LabialisPhase 3NCT05098938
A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally
A Phase 3 study testing Acyclovir 50mg buccal/topical tablet, BAYM008894/UI1614773 in people with Recurrent Herpes Labialis, run by Bayer at 1 site in United States.
Trial summary
Researchers are looking for a better way to treat people who have recurrent herpes labialis, also known as cold sores. This is a type of viral infection that causes redness and blisters on the mouth and lip and that recurs. Herpes labialis is caused by a virus called the herpes simplex virus (HSV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Herpes Labialis
- What is being tested?
- Acyclovir 50mg buccal/topical tablet, BAYM008894/UI1614773
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,020 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2021to 2 Jul 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, 18 years of age or older inclusive;
- History of recurrent HL lesions where:
- Recurrence is defined as at least 4 episodes in the preceding 12 months;
- At least half of the episodes should be vesicular in nature;
- At least half of the episodes should be preceded by prodromal symptoms;
- Herpes labialis lesions are characterized by their localization on the cutaneous and/or mucosal surfaces of the lips;
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- Willing to avoid, during the treatment phase, the use of anti-inflammatory (not including low-dose (81 mg) aspirin), anti-herpetic, antibiotic and antiviral agents as well as steroids or other natural products that would interfere with the immune system response;
- Female participants of childbearing potential must be using a medically acceptable form of birth control during screening [e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), implantable device (implantable rod or intrauterine device), or a double barrier], abstinence or in same sex relationship and have a negative pregnancy test at Screening and prior to study drug administration. Female participants of non-childbearing potential must be amenorrheic for at least two years or have undergone surgical sterilization (i.e. tubal ligation/occlusion, hysterectomy and/or bilateral oophorectomy);
- Agreement to abstain from any mechanical disruption of the prodromal area or lesion (i.e. scrubbing, lancing, shaving the area, rubbing with alcohol, application of heat emitting devices used for cold sore treatment, etc.);
- Capable of giving signed informed consent as described in protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol;
- Ability to understand and follow study-related instructions;
- Be willing and able to participate in all scheduled visits, treatment plan, and trial procedures according to the clinical protocol.
Who cannot join
- Participants who did not develop herpes prodromal symptoms within 6 months after randomization in the study;
- More than 50% of recurrences that aborted spontaneously (without intervention) in the past 12 months;
- Primary herpes lesion outside the lips (e.g., nose, chin, etc.);
- Abnormal peri-oral skin condition that might affect the normal course of cold sores (e.g., eczema, psoriasis, etc.);
- Oral diseases whose prodromal symptoms may mimic those of herpes labialis, including recurrent oral aphthous disease;
- Allergy to any acyclovir or its containing agents;
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- Milk allergy or known history of hypersensitivity to one of the components of Sitavig;
- Self-reported immunocompromised condition, including self-reported Human Immunodeficiency Virus (HIV) positive and previous bone marrow or organ transplant;
- Known medical history of renal disease, that in the judgment of the investigator is severe;
- Females who are planning to become pregnant, are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multi-Center, Double Blinded, Self-Initiated, Single Treatment Study Comparing Sitavig® (Acyclovir) 50 mg Muco-adhesive Buccal Tablet to Placebo in the Treatment of Herpes Labialis in Immunocompetent Adults
Researchers are looking for a better way to treat people who have recurrent herpes labialis, also known as cold sores. This is a type of viral infection that causes redness and blisters on the mouth and lip and that recurs.
Herpes labialis is caused by a virus called the herpes simplex virus (HSV). The infection is spread when a person comes into direct contact with someone else who has the infection. Once a person becomes infected with HSV, the virus multiplies and spreads, which can cause redness and blistering on the mouth and lip. The blisters crust over and heal. Once healed, the virus is said to go into an "inactive" phase. This means the virus does not cause any symptoms, but still remains in the body. HSV can then become "active" again. This means causing cold sore lesions to reappear. HSV can become active in different ways. Some of these include when a person has a fever, comes into contact with strong sunlight or has a condition that lowers one's immune system It can also happen during a woman's menstrual cycle, also called a period.
Read more
In this study, the researchers want to gather additional data on acyclovir 50 mg tablet, an available treatment for herpes labialis. It is a buccal tablet that sticks to the gum inside the mouth and directly treats the infected area to help stop the HSV from multiplying and spreading.
In this study, the researchers want to compare the efficacy of acyclovir 50 mg buccal tablets versus placebo in the treatment of herpes labialis. A placebo is a treatment that looks like the study medicine but does not have any medicine in it. Study participants will include those who have had at least 4 episodes of herpes labialis within the past 12 months prior to joining the study. To compare the study treatments, the researchers will measure the "duration of episode" (DOE) for each participant. DOE is amount of time it takes for symptoms to disappear and for herpes labialis lesions to heal after taking the study treatment. A doctor will look at the participants' symptom scores and facial images to determine the DOE. Assessments will be done over a period of 14 days.
The participants in this study will apply either acyclovir 50mg buccal tablet or the placebo as a tablet to the upper gum 1 time.
There will be a 2 week treatment phase and a 12 month follow up phase. The participants in this study will not be required to visit the study site. Instead, the participants will have virtual meetings with the study doctors from their homes using the internet. During the treatment phase, there will be 2 meetings. Throughout the follow up phase, the doctors will call the participants 4 times. Each participant will be in the study for about 20 months.
During the treatment phase of the study, the participants will:
- take their blood pressure and pulse
- check their mouth health through a questionnaire
- take pictures of their face and herpes labialis symptoms During the whole study the participants will answer questions about how they are feeling, what medications they are taking, and what adverse events they are having.
The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
Read the detailed description
Participants will be randomly assigned one of two treatment groups - acyclovir 50 mg buccal tablet or a placebo buccal tablet. Face images as well as symptom scores will be recorded at baseline, treatment initiation and over the next 14 days. Participants will automatically transition to the Follow-up Phase. Participants will be in contact with the sites using weekly virtual check-ins with the e-diary/App with the purpose reporting any adverse events, concomitant medications , or new outbreaks of herpes labialis.
- Conditions
- Recurrent Herpes Labialis
- Being tested
- Acyclovir 50mg buccal/topical tablet, BAYM008894/UI1614773, Placebo
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acyclovir 50mg buccal/topical tablet, BAYM008894/UI1614773Drug
Oral (upper gum area), 50mg, 1 tablet.
PlaceboDrug
Oral (upper gum area), 1 table.
| Study group | Role | What they receive |
|---|---|---|
| Acyclovir 50mg buccal/topical tablet treatment group | Experimental | Not described Receives: Drug: Acyclovir 50mg buccal/topical tablet, BAYM008894/UI1614773 |
| Matching placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Episode (DOE) Was Measured in Hours (Using the Science 37 Platform), of a Single Treated Herpes Labialis (HL) Lesion
Duration of episode (DOE) is defined as the time from the initiation of treatment (study intervention) to the healing of primary lesions (loss of crust) for participants who experience a vesicular lesion.
For participants whose primary lesions are not vesicular in nature, duration of episode is the time from study intervention initiation to the return to normal skin as determined by the independent blinded reader of the participant's face images using a 6-point Likert scale or to the cessation of symptoms, whichever comes last.
Measured: Up to 14 days
Secondary outcomes (5)
Incidence of Aborted Lesions
Incidence of aborted lesions, defined as treated HL lesions that do not progress to the vesicular or crust stage. A lesion that returns to normal skin without forming a vesicle or crust will be counted as an aborted lesion.
Measured: Up to 14 days
Incidence of Recurrence of HL Lesions During the 12-months Follow-up Period
Measured: Up to 12 months
Time to Recurrence of HL Lesions, Measured in Days From Resolution of the Cold Sore Treated in the Treatment Phase Until Onset of Prodromal Symptoms
Measured: Up to 12 months
Incidence of Treatment-Emergent Adverse Events (TEAE)s
Measured: Up to 12 months
Percentage of Participants Who Have at Least One Recurrence
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start23 Nov 2021
- Primary completion19 Jul 2023
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Herpes LabialisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098938
- Sponsor's protocol ID
- 21755
- Status last verified
- Jul 2025
- First submitted
- 18 Oct 2021
- Last updated
- 2 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-Center, Double Blinded, Self-Initiated, Single Treatment Study Comparing Sitavig® (Acyclovir) 50 mg Muco-adhesive Buccal Tablet to Placebo in the Treatment of Herpes Labialis in Immunocompetent Adults
- ClinicalTrials.gov ID
- NCT05098938
- Acronym / sponsor ID
- 21755
- Conditions
- Recurrent Herpes Labialis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,020 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 28 Oct 2021 (actual)
- Results
- Posted 2 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are looking for a better way to treat people who have recurrent herpes labialis, also known as cold sores. This is a type of viral infection that causes redness and blisters on the mouth and lip and that recurs.
Herpes labialis is caused by a virus called the herpes simplex virus (HSV). The infection is spread when a person comes into direct contact with someone else who has the infection. Once a person becomes infected with HSV, the virus multiplies and spreads, which can cause redness and blistering on the mouth and lip. The blisters crust over and heal. Once healed, the virus is said to go into an "inactive" phase. This means the virus does not cause any symptoms, but still remains in the body. HSV can then become "active" again. This means causing cold sore lesions to reappear. HSV can become active in different ways. Some of these include when a person has a fever, comes into contact with strong sunlight or has a condition that lowers one's immune system It can also happen during a woman's menstrual cycle, also called a period.
In this study, the researchers want to gather additional data on acyclovir 50 mg tablet, an available treatment for herpes labialis. It is a buccal tablet that sticks to the gum inside the mouth and directly treats the infected area to help stop the HSV from multiplying and spreading.
In this study, the researchers want to compare the efficacy of acyclovir 50 mg buccal tablets versus placebo in the treatment of herpes labialis. A placebo is a treatment that looks like the study medicine but does not have any medicine in it. Study participants will include those who have had at least 4 episodes of herpes labialis within the past 12 months prior to joining the study. To compare the study treatments, the researchers will measure the "duration of episode" (DOE) for each participant. DOE is amount of time it takes for symptoms to disappear and for herpes labialis lesions to heal after taking the study treatment. A doctor will look at the participants' symptom scores and facial images to determine the DOE. Assessments will be done over a period of 14 days.
The participants in this study will apply either acyclovir 50mg buccal tablet or the placebo as a tablet to the upper gum 1 time.
There will be a 2 week treatment phase and a 12 month follow up phase. The participants in this study will not be required to visit the study site. Instead, the participants will have virtual meetings with the study doctors from their homes using the internet. During the treatment phase, there will be 2 meetings. Throughout the follow up phase, the doctors will call the participants 4 times. Each participant will be in the study for about 20 months.
During the treatment phase of the study, the participants will:
- take their blood pressure and pulse
- check their mouth health through a questionnaire
- take pictures of their face and herpes labialis symptoms During the whole study the participants will answer questions about how they are feeling, what medications they are taking, and what adverse events they are having.
The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
Detailed description
Participants will be randomly assigned one of two treatment groups - acyclovir 50 mg buccal tablet or a placebo buccal tablet. Face images as well as symptom scores will be recorded at baseline, treatment initiation and over the next 14 days. Participants will automatically transition to the Follow-up Phase. Participants will be in contact with the sites using weekly virtual check-ins with the e-diary/App with the purpose reporting any adverse events, concomitant medications , or new outbreaks of herpes labialis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acyclovir 50mg buccal/topical tablet treatment group | Experimental | Drug: Acyclovir 50mg buccal/topical tablet, BAYM008894/UI1614773 |
| Matching placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males or females, 18 years of age or older inclusive;
- History of recurrent HL lesions where:
- Willing to avoid, during the treatment phase, the use of anti-inflammatory (not including low-dose (81 mg) aspirin), anti-herpetic, antibiotic and antiviral agents as well as steroids or other natural products that would interfere with the immune system response;
- Female participants of childbearing potential must be using a medically acceptable form of birth control during screening [e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), implantable device (implantable rod or intrauterine device), or a double barrier], abstinence or in same sex relationship and have a negative pregnancy test at Screening and prior to study drug administration. Female participants of non-childbearing potential must be amenorrheic for at least two years or have undergone surgical sterilization (i.e. tubal ligation/occlusion, hysterectomy and/or bilateral oophorectomy);
- Agreement to abstain from any mechanical disruption of the prodromal area or lesion (i.e. scrubbing, lancing, shaving the area, rubbing with alcohol, application of heat emitting devices used for cold sore treatment, etc.);
Key exclusion criteria (10 listed)
- Participants who did not develop herpes prodromal symptoms within 6 months after randomization in the study;
- More than 50% of recurrences that aborted spontaneously (without intervention) in the past 12 months;
- Primary herpes lesion outside the lips (e.g., nose, chin, etc.);
- Abnormal peri-oral skin condition that might affect the normal course of cold sores (e.g., eczema, psoriasis, etc.);
- Oral diseases whose prodromal symptoms may mimic those of herpes labialis, including recurrent oral aphthous disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acyclovir 50mg buccal/topical tablet, BAYM008894/UI1614773Oral (upper gum area), 50mg, 1 tablet. | Drug | Acyclovir 50mg buccal/topical tablet treatment group |
| PlaceboOral (upper gum area), 1 table. | Drug | Matching placebo group |
Primary outcome
Duration of Episode (DOE) Was Measured in Hours (Using the Science 37 Platform), of a Single Treated Herpes Labialis (HL) Lesion
Time frame: Up to 14 days
Duration of episode (DOE) is defined as the time from the initiation of treatment (study intervention) to the healing of primary lesions (loss of crust) for participants who experience a vesicular lesion. For participants whose primary lesions are not vesicular in nature, duration of episode is the time from study intervention initiation to the return to normal skin as determined by the independent blinded reader of the participant's face images using a 6-point Likert scale or to the cessation of symptoms, whichever comes last.
5 secondary outcomes
Incidence of Aborted Lesions
Time frame: Up to 14 days
Incidence of Recurrence of HL Lesions During the 12-months Follow-up Period
Time frame: Up to 12 months
Time to Recurrence of HL Lesions, Measured in Days From Resolution of the Cold Sore Treated in the Treatment Phase Until Onset of Prodromal Symptoms
Time frame: Up to 12 months
Incidence of Treatment-Emergent Adverse Events (TEAE)s
Time frame: Up to 12 months
Percentage of Participants Who Have at Least One Recurrence
Time frame: Up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acyclovir 50mg buccal/topical tablet, BAYM008894/UI1614773 in people with Recurrent Herpes Labialis, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Episode (DOE) Was Measured in Hours (Using the Science 37 Platform), of a Single Treated Herpes Labialis (HL) Lesion (time frame: Up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.