- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02265913
Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis
October 20, 2021 updated by: Padagis LLC
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4076
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68114
- Quality Clinical Research Inc
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
- 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.
- Presence of any facial skin condition or excessive facial hair that may interfere with diagnosis, assessment, and/or healing ability.
- History of herpes keratitis.
- Subject has a history of hypersensitivity or allergy to any ingredient in the drug product.
- History of unresponsiveness to topical acyclovir therapy.
- Participation in any other clinical study or who have received treatment with any investigational drug or device within 30 days prior to screening.
- Subjects who have previously enrolled in this study.
- Subjects who have received any local medication in the target area during the 2 weeks prior to both enrollment/screening and Day 1 (Visit 2).
- Subjects who have been treated with immunosuppressive medication therapy within 8 weeks prior to the study both enrollment/screening and Day 1 (Visit 2).
- Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements in the investigator's opinion.
- Use of tanning booths, sun lamps, or excessive exposure to the sun for up to 21 days from initiating study medication
- Subjects using immunostimulators, dye-light therapy, or psoralen therapy within 30 days prior to study medication initiation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test Product
acyclovir cream
|
Other Names:
|
Active Comparator: Reference Product
acyclovir cream
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Other Names:
|
Placebo Comparator: Placebo Product
Placebo cream
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lesion Healing
Time Frame: up to 21 days
|
Time to complete healing of lesions measured in hours from the time of first dosing
|
up to 21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 6, 2014
Primary Completion (Actual)
April 27, 2016
Study Completion (Actual)
November 21, 2017
Study Registration Dates
First Submitted
October 10, 2014
First Submitted That Met QC Criteria
October 15, 2014
First Posted (Estimate)
October 16, 2014
Study Record Updates
Last Update Posted (Actual)
October 22, 2021
Last Update Submitted That Met QC Criteria
October 20, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRG-NY-14-008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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