CompletedPhase 3

Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis

United States4,076 participantsStarted 2014-10-06

Plain-language summary

To compare safety and efficacy of Perrigo's antiviral drug product compared to an FDA approved antiviral drug product in the treatment of cold sores.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provides written informed consent/assent
. Immunocompetent male or non-pregnant females, \>12 years old, with limited, non-life-threatening, recurrent herpes simplex labialis.
. Subjects must have at least 3 recurrences of herpes simplex labialis per year for the past two years.
. Females of childbearing potential willing to use an acceptable form of birth control.
. Subjects must be in general good health with no clinically significant disease that might interfere with the study evaluations in the opinion of the investigator.
. Subjects must be willing and able to understand and comply with the requirements of the study.

Exclusion criteria

. Females who are pregnant or nursing, are not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study.
. The use of antiviral therapies in various forms for a given period of time prior to screening and study medication application.
. Candidate for or previous use of parenteral antiviral treatment or prophylactic antiviral therapy for their recurrent herpes simplex labialis.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Lesion Healing

Timeframe: up to 21 days

Trial details

NCT IDNCT02265913

SponsorPadagis LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-04-27

Results submitted2020-10-26

View on ClinicalTrials.gov More Herpes Labialis trials