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.

Age range12 Years

SexALL

See this in plain English?

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

✓. 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.

✕. 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.
✕. Recently received an organ transplant.
✕. Subjects who are immunocompromised, HIV positive or who have any immune-system disorders.
✕. Recent major change in immune system status that could seriously affect the clinical manifestations of herpes simplex labialis and need for treatment in the opinion of the investigator.
✕. Subjects with known or suspected history of a clinically significant systemic disease, unstable medical disorders, life-threatening disease or current malignancies.
✕. Subjects with a current episode of herpes simplex labialis that has not completely healed.

Lesion Healing

Timeframe: up to 21 days

NCT IDNCT02265913

SponsorPadagis LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-04-27

Results submitted2020-10-26

Who can participate

Age range12 Years

SexALL

See this in plain English?

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

✓. 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.

✕. 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.
✕. Recently received an organ transplant.
✕. Subjects who are immunocompromised, HIV positive or who have any immune-system disorders.
✕. Recent major change in immune system status that could seriously affect the clinical manifestations of herpes simplex labialis and need for treatment in the opinion of the investigator.
✕. Subjects with known or suspected history of a clinically significant systemic disease, unstable medical disorders, life-threatening disease or current malignancies.
✕. Subjects with a current episode of herpes simplex labialis that has not completely healed.