Trial · NCT05098938
A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally
NCT05098938, Phase 3, Completed, Bayer; results first posted 2025-09-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally. Trials, record NCT05098938. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05098938
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally
- NCT number
- NCT05098938
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,020 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Recurrent Herpes Labialis
- Interventions
- Acyclovir 50mg buccal/topical tablet, BAYM008894/UI1614773, Placebo
- First posted
- 2021-10-28
- Last updated
- 2025-09-02
- Results first posted
- 2025-09-02
- Limitations and caveats
Initial results (Feb 2024) indicated significant data inconsistencies. After quality analysis of the data, it appears that the contract research organization (CRO) did not read the facial images correctly, which are the data source for the primary endpoint.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Duration of Episode (DOE) Was Measured in Hours (Using the Science 37 Platform), of a Single Treated Herpes Labialis (HL) Lesion | 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. |
| Secondary | Incidence of Aborted Lesions | Up to 14 days | 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. |
| Secondary | Incidence of Recurrence of HL Lesions During the 12-months Follow-up Period | Up to 12 months | |
| Secondary | 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 | Up to 12 months | |
| Secondary | Incidence of Treatment-Emergent Adverse Events (TEAE)s | Up to 12 months | |
| Secondary | Percentage of Participants Who Have at Least One Recurrence | Up to 12 months |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Duration of Episode (DOE) Was Measured in Hours (Using the Science 37 Platform), of a Single Treated Herpes Labialis (HL) Lesion | Up to 14 days | PP population: The Per Protocol (PP) population included all subjects who completed 14-days of evaluations and did not have any major protocol violations. | Hours | MEDIAN |
| SECONDARY | Incidence of Aborted Lesions | Up to 14 days | PP population: The Per Protocol (PP) population included all subjects in ITT who completed 14-days of evaluations and did not have any major protocol violations. | lesions | NUMBER |
| SECONDARY | Incidence of Recurrence of HL Lesions During the 12-months Follow-up Period | Up to 12 months | Follow-up population: The follow-up population included all participants, who continued into the 12-months Follow-up period and was defined as participants whose lesions were all treated at the end of the treament period (of 14 days) of the study. | lesions | NUMBER |
| SECONDARY | 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 | Up to 12 months | Follow-up population: The follow-up population included all participants, who continued into the 12-months Follow-up period and was defined as participants whose lesions were all treated at the end of the treament period (of 14 days) of the study. | days | MEDIAN |
| SECONDARY | Incidence of Treatment-Emergent Adverse Events (TEAE)s | Up to 12 months | Safety analysis set | participants | NUMBER |
| SECONDARY | Percentage of Participants Who Have at Least One Recurrence | Up to 12 months | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Duration of Episode (DOE) Was Measured in Hours (Using the Science 37 Platform), of a Single Treated Herpes Labialis (HL) Lesion | Sitavig | 66.5 | 95% Confidence Interval 55.4 to 74.7 | Hours | |
| Duration of Episode (DOE) Was Measured in Hours (Using the Science 37 Platform), of a Single Treated Herpes Labialis (HL) Lesion | Placebo | 73.6 | 95% Confidence Interval 65.5 to 85.2 | Hours | |
| Incidence of Aborted Lesions | Sitavig | 40 | lesions | ||
| Incidence of Aborted Lesions | Placebo | 58 | lesions | ||
| Incidence of Recurrence of HL Lesions During the 12-months Follow-up Period | Sitavig | 117 | lesions | ||
| Incidence of Recurrence of HL Lesions During the 12-months Follow-up Period | Placebo | 94 | lesions | ||
| 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 | Sitavig | 88.0 | 95% Confidence Interval 63.0 to 108.0 | days | |
| 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 | Placebo | 88.0 | 95% Confidence Interval 65.0 to 106.0 | days | |
| Incidence of Treatment-Emergent Adverse Events (TEAE)s | Sitavig | Participants with TEAEs | 146 | participants | |
| Incidence of Treatment-Emergent Adverse Events (TEAE)s | Placebo | Participants with TEAEs | 149 | participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sitavig | 1,009 | |
| Overall Study | STARTED | Placebo | 1,011 | |
| Overall Study | COMPLETED | Sitavig | 372 | |
| Overall Study | COMPLETED | Placebo | 369 | |
| Overall Study | NOT COMPLETED | Sitavig | 637 | |
| Overall Study | NOT COMPLETED | Placebo | 642 |
Source ClinicalTrials.gov
Adverse events392
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Sitavig | 0 | 504 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 2 | 497 | 3 |
| other | Abdominal distension | Gastrointestinal disorders | Sitavig | 0 | 504 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 1 | 497 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Sitavig | 0 | 504 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 1 | 497 | 1 |
| other | Acne | Skin and subcutaneous tissue disorders | Sitavig | 0 | 504 | 0 |
| other | Acne | Skin and subcutaneous tissue disorders | Placebo | 1 | 497 | 1 |
| other | Allergic respiratory disease | Respiratory, thoracic and mediastinal disorders | Sitavig | 1 | 504 | 1 |
| other | Allergic respiratory disease | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 497 | 0 |
1 to 10 of 392Source ClinicalTrials.gov
See all 392 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitavig | 1 | 504 |
| Total, all-cause mortality | Placebo | 0 | 497 |
| Total, other adverse events | Sitavig | 143 | 504 |
| Total, other adverse events | Placebo | 146 | 497 |
| Total, serious adverse events | Sitavig | 5 | 504 |
| Total, serious adverse events | Placebo | 7 | 497 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sitavig vs Placebo: deaths from any cause | Trial comparisons |
| Sitavig vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05098938
GET https://conductscience.org/api/trials/v1/NCT05098938/events?page=2