Trial Outcomes & Findings for 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 NCT05098938)

Last Updated: 2025-09-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2020 participants

Primary outcome timeframe

Up to 14 days

Results posted on

2025-09-02

Participant Flow

The study was conducted in the United States of America (USA) as a decentralized study between 23 Nov 2021 (First participant first visit) and 2 July 2024 (Last participant last visit).

2020 participants were randomized into the study, 1009 in the Sitavig arm and 1011 in the Placebo arm. 1019 participants were run-in failure, 505 in the Sitavig arm and 514 in the Placebo arm, so that 504 participants were included in the Sitavig arm and 497 in the Placebo arm.

Participant milestones

Participant milestones
Measure	Sitavig Sitavig (acyclovir) 50 mg muco-adhesive buccal tablet (one tablet application on Day 1)	Placebo Placebo muco-adhesive buccal tablet (one tablet application on Day 1)
Overall Study STARTED	1009	1011
Overall Study COMPLETED	372	369
Overall Study NOT COMPLETED	637	642

Reasons for withdrawal

Reasons for withdrawal
Measure	Sitavig Sitavig (acyclovir) 50 mg muco-adhesive buccal tablet (one tablet application on Day 1)	Placebo Placebo muco-adhesive buccal tablet (one tablet application on Day 1)
Overall Study Adverse Event	4	3
Overall Study inclusion/exclusion criteria change	11	5
Overall Study lack of compliance	26	19
Overall Study Lost to Follow-up	37	40
Overall Study Lost in treatment period	17	13
Overall Study Met an exclusion criterion	0	3
Overall Study no prodromal symptoms after 6 months	1	0
Overall Study Physician Decision	25	32
Overall Study Run in failure in treatment phase	1	1
Overall Study Withdrawal by Subject	0	3
Overall Study Run-in Failure in early study	505	514
Overall Study IMP delivery missed	1	5
Overall Study 6 months visit was missed	2	0
Overall Study fit for use was not completed within window	3	0
Overall Study V2 visit was not completed within window	0	1
Overall Study exclusionary medication use	1	2
Overall Study change in medication	1	0
Overall Study treatment failure	2	1

Baseline Characteristics

A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sitavig n=493 Participants Sitavig (acyclovir) 50 mg muco-adhesive buccal tablet (one tablet application on Day 1)	Placebo n=483 Participants Placebo muco-adhesive buccal tablet (one tablet application on Day 1)	Total n=976 Participants Total of all reporting groups
Age, Continuous	42.7 Years STANDARD_DEVIATION 12.38 • n=5 Participants	43.0 Years STANDARD_DEVIATION 12.19 • n=7 Participants	42.9 Years STANDARD_DEVIATION 12.28 • n=5 Participants
Sex: Female, Male Female	402 Participants n=5 Participants	399 Participants n=7 Participants	801 Participants n=5 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	84 Participants n=7 Participants	175 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	43 Participants n=5 Participants	37 Participants n=7 Participants	80 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	450 Participants n=5 Participants	445 Participants n=7 Participants	895 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 14 days

Population: PP population: The Per Protocol (PP) population included all subjects who completed 14-days of evaluations and did not have any major protocol violations.

Outcome measures

Outcome measures
Measure	Sitavig n=330 Participants Sitavig (acyclovir) 50 mg muco-adhesive buccal tablet (one tablet application on Day 1)	Placebo n=349 Participants Placebo muco-adhesive buccal tablet (one tablet application on Day 1)
Duration of Episode (DOE) Was Measured in Hours (Using the Science 37 Platform), of a Single Treated Herpes Labialis (HL) Lesion	66.5 Hours Interval 55.4 to 74.7	73.6 Hours Interval 65.5 to 85.2

SECONDARY outcome

Timeframe: Up to 14 days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Sitavig n=330 Participants Sitavig (acyclovir) 50 mg muco-adhesive buccal tablet (one tablet application on Day 1)	Placebo n=349 Participants Placebo muco-adhesive buccal tablet (one tablet application on Day 1)
Incidence of Aborted Lesions	40 lesions	58 lesions

SECONDARY outcome

Timeframe: Up to 12 months

Population: 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.

Outcome measures

Outcome measures
Measure	Sitavig n=378 Participants Sitavig (acyclovir) 50 mg muco-adhesive buccal tablet (one tablet application on Day 1)	Placebo n=400 Participants Placebo muco-adhesive buccal tablet (one tablet application on Day 1)
Incidence of Recurrence of HL Lesions During the 12-months Follow-up Period	117 lesions	94 lesions

SECONDARY outcome

Timeframe: Up to 12 months

Outcome measures

Outcome measures
Measure	Sitavig n=378 Participants Sitavig (acyclovir) 50 mg muco-adhesive buccal tablet (one tablet application on Day 1)	Placebo n=400 Participants Placebo muco-adhesive buccal tablet (one tablet application on Day 1)
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	88.0 days Interval 63.0 to 108.0	88.0 days Interval 65.0 to 106.0

SECONDARY outcome

Timeframe: Up to 12 months

Population: Safety analysis set

Outcome measures

Outcome measures
Measure	Sitavig n=504 Participants Sitavig (acyclovir) 50 mg muco-adhesive buccal tablet (one tablet application on Day 1)	Placebo n=497 Participants Placebo muco-adhesive buccal tablet (one tablet application on Day 1)
Incidence of Treatment-Emergent Adverse Events (TEAE)s Participants with TEAEs	146 participants	149 participants
Incidence of Treatment-Emergent Adverse Events (TEAE)s Participants with serious TEAEs	4 participants	6 participants
Incidence of Treatment-Emergent Adverse Events (TEAE)s Participants with treatment related TEAEs	16 participants	10 participants
Incidence of Treatment-Emergent Adverse Events (TEAE)s Participants with treatment related serious TEAEs	0 participants	0 participants
Incidence of Treatment-Emergent Adverse Events (TEAE)s Participants with TEAEs leading to study discontinuation	0 participants	0 participants

SECONDARY outcome

Timeframe: Up to 12 months

Outcome measures

Outcome measures
Measure	Sitavig n=378 Participants Sitavig (acyclovir) 50 mg muco-adhesive buccal tablet (one tablet application on Day 1)	Placebo n=400 Participants Placebo muco-adhesive buccal tablet (one tablet application on Day 1)
Percentage of Participants Who Have at Least One Recurrence	31.0 percentage of participants	23.5 percentage of participants

Adverse Events

Sitavig

Serious events: 5 serious events

Other events: 143 other events

Deaths: 1 deaths

Placebo

Serious events: 7 serious events

Other events: 146 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sitavig n=504 participants at risk Sitavig (acyclovir) 50 mg muco-adhesive buccal tablet (one tablet application on Day 1)	Placebo n=497 participants at risk Placebo muco-adhesive buccal tablet (one tablet application on Day 1)
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/504 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.	0.20% 1/497 • Number of events 1 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.
Infections and infestations Bronchitis	0.20% 1/504 • Number of events 1 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.	0.00% 0/497 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.
Hepatobiliary disorders Cholelithiasis	0.00% 0/504 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.	0.20% 1/497 • Number of events 1 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.
General disorders Death	0.20% 1/504 • Number of events 1 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.	0.00% 0/497 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.
Infections and infestations Diverticulitis	0.00% 0/504 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.	0.20% 1/497 • Number of events 1 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.
Surgical and medical procedures Hernia hiatus repair	0.00% 0/504 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.	0.20% 1/497 • Number of events 1 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/504 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.	0.20% 1/497 • Number of events 1 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.
Nervous system disorders Neuralgia	0.00% 0/504 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.	0.20% 1/497 • Number of events 1 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.
Cardiac disorders Pericarditis	0.20% 1/504 • Number of events 1 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.	0.00% 0/497 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.
Infections and infestations Pneumonia	0.20% 1/504 • Number of events 1 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.	0.00% 0/497 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.
Cardiac disorders Supraventricular tachycardia	0.20% 1/504 • Number of events 1 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.	0.00% 0/497 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/504 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.	0.20% 1/497 • Number of events 1 • From signing of the consent form until 12 months after end of study intervention, up to 18 months. Adverse Events were collected on the Safety Population, i.e. all randomized participants who took at least one dose of study intervention.

Other adverse events

Additional Information

Therapeutic Area Head

Bayer

Phone: (+) 1-888-8422937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Per Master Service Agreement between Bayer and Science 37 dated 08-Apr-2019, Science 37 shall have no rights of publication whatsoever in connection with the Study nor will Science 37 assist any other Party in the preparation of a publication. Publication of results in whole or in part, shall be within the sole and absolute discretion of Bayer, and such shall not be unreasonably withheld.
Publication restrictions are in place

Restriction type: OTHER