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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Agreement to abstain from any mechanical disruption of the prodromal area or lesion
Recurrence is defined as at least 4 episodes in the preceding 12 months;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is being done to study the efficacy of acyclovir 50mg buccal tablet in the treatment of recurrent herpes labialis, also known as cold sores. Acyclovir is a medication used to treat viral infections and the tablet form sticks to the inside of the mouth to directly treat the infected area. The study will compare the duration of the episode for those taking acyclovir 50mg buccal tablet to those taking a placebo. There will be 2 weeks of treatment and a 12 month follow up phase with virtual meetings from home using the internet.
Who is the study for?
Adults 18+ with frequent cold sores (at least 4 episodes in the past year) can join this trial. Participants must not disturb their cold sore lesions, be willing to avoid certain medications and treatments that affect immune response, and follow study instructions. Women of childbearing age need effective birth control and a negative pregnancy test.Check my eligibility
What is being tested?
The trial is testing if a buccal tablet containing Acyclovir (50mg), which sticks to the gum inside the mouth, is more effective than a placebo at treating herpes labialis. The main focus is on how quickly symptoms disappear after treatment over a period of up to 20 months with virtual check-ins.See study design
What are the potential side effects?
Possible side effects include allergic reactions for those sensitive to acyclovir or its components, though specific side effects are not listed; all medical problems during the study will be tracked as adverse events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree not to disturb the area where my disease might start or has started.
Select...
I have had at least 4 episodes of my condition in the last year.
Select...
My Hodgkin's lymphoma has come back after treatment.
Select...
I am able to understand and sign the consent form.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of episode (DOE) will be measured in hours (using the Science 37 Platform), of a single treated HL lesion
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events
Incidence of aborted lesions
Incidence of recurrence of HL lesions during the 12-month follow-up period
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Acyclovir 50mg buccal/topical tablet treatment groupExperimental Treatment1 Intervention
Group II: Matching placebo groupPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
BayerLead Sponsor
2,237 Previous Clinical Trials
25,324,959 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree not to disturb the area where my disease might start or has started.I am allergic to acyclovir or similar medications.I am using birth control and my pregnancy test was negative.I have had at least 4 episodes of my condition in the last year.My Hodgkin's lymphoma has come back after treatment.Over half of my health issues resolved on their own in the last year.I have oral conditions that could be confused with cold sores.I am 18 years old or older.I am able to understand and sign the consent form.I am 18 years old or older.I have a skin condition near my mouth that could worsen cold sores.I have a condition that weakens my immune system, such as HIV or a past transplant.My primary herpes sore is not on my lips.You have a history of recurring herpes labialis (cold sores) on your lips, with at least 4 episodes in the past year, and half of these episodes involving vesicular sores preceded by prodromal symptoms. During the treatment phase, you must avoid using anti-inflammatory, anti-herpetic, antibiotic, and antiviral medications, as well as steroids or natural products that can affect your immune system. You must also agree to abstain from any mechanical disruption of the prodromal area or lesion. Female participants of childbearing potential must be using effective birth control and have a negative pregnancy test. Additionally, you must be able to understand and follow study-related instructions, participate in all scheduled visits and trial procedures, and give informed consent.I am using reliable birth control or am not able to have children due to age or surgery.More than half of my episodes involve blister-like lesions.You are allergic to milk or any part of Sitavig.You have not shown symptoms of herpes within 6 months of joining the study.I am pregnant, breastfeeding, or planning to become pregnant.I have a history of severe kidney disease.
Research Study Groups:
This trial has the following groups:- Group 1: Acyclovir 50mg buccal/topical tablet treatment group
- Group 2: Matching placebo group
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cold Sores Patient Testimony for trial: Trial Name: NCT05098938 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is Acyclovir 50mg buccal tablet, BAYM008894/UI1614773 most frequently prescribed for?
"The Acyclovir 50mg buccal tablet, BAYM008894/UI1614773, can be used to manage chickenpox, herpes labialis, and vzv re-activation."
Answered by AI
Are there any other research projects that have looked at Acyclovir 50mg buccal tablet, BAYM008894/UI1614773?
"At this time, there are four ongoing studies investigating Acyclovir 50mg buccal tablet, BAYM008894/UI1614773 in Phase 3 trials. These studies are being conducted at 52 locations, with many of them in Culver City, California."
Answered by AI
How many test subjects are taking part in this clinical trial?
"Indeed, the clinical trial is currently ongoing, as reflected on clinicaltrials.gov. 1820 patients are needed at a single site, with the trial having first been posted on November 23rd, 2021."
Answered by AI
Are participants still being gathered for this experiment?
"Yes, this is an active clinical trial that was first posted on November 23rd, 2021 and is last edited on October 9th, 2022. The trial is looking for a total of 1820 participants at 1 site."
Answered by AI
What risks are associated with Acyclovir 50mg buccal tablet, BAYM008894/UI1614773?
"Acyclovir 50mg buccal tablet, BAYM008894/UI1614773, is a Phase 3 trial medication. This means that, while there is some evidence of efficacy, the safety of the drug has been supported by multiple rounds of testing. Our team rates the safety of this drug as a 3."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
Washington
Other
California
How old are they?
18 - 65
What site did they apply to?
Science 37
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have had genital and oral herpes since 2010 and am just looking for anything to treat it.
PatientReceived 2+ prior treatments
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