Herpes LabialisPhase 3NCT02265913
Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis
A Phase 3 study testing Acyclovir 5 percent (Perrigo) and Acyclovir 5 percent (Reference) in people with Herpes Labialis, run by Padagis LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- Acyclovir 5 percent (Perrigo) and Acyclovir 5 percent (Reference)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,076 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2014to 21 Nov 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Quality Clinical Research Inc
Omaha, Nebraska, 68114
About this study
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.
- Conditions
- Herpes Labialis
- Being tested
- Acyclovir 5 percent (Perrigo), Acyclovir 5 percent (Reference), Placebo cream
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acyclovir 5 percent (Perrigo)Drug
Also called Perrigo product
Acyclovir 5 percent (Reference)Drug
Also called Reference Listed Drug Product
Placebo creamDrug
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | acyclovir cream Receives: Drug: Acyclovir 5 percent (Perrigo) |
| Reference Product | Active comparator | acyclovir cream Receives: Drug: Acyclovir 5 percent (Reference) |
| Placebo Product | Placebo comparator | Placebo cream Receives: Drug: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion Healing
Time to complete healing of lesions measured in hours from the time of first dosing
Measured: up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study start6 Oct 2014
- Primary completion27 Apr 2016
- Study completion21 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Herpes LabialisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4,076 participants (actual)
Sponsor and investigators
- Lead sponsor
- Padagis LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265913
- Sponsor's protocol ID
- PRG-NY-14-008
- Status last verified
- Oct 2021
- First submitted
- 10 Oct 2014
- Last updated
- 22 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis
- ClinicalTrials.gov ID
- NCT02265913
- Acronym / sponsor ID
- PRG-NY-14-008
- Conditions
- Herpes Labialis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,076 participants (actual)
- Lead sponsor
- Padagis LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2014 (actual)
- Primary completion
- 27 Apr 2016 (actual)
- Study completion
- 21 Nov 2017 (actual)
- First posted
- 16 Oct 2014 (estimated)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: Acyclovir 5 percent (Perrigo)acyclovir cream |
| Reference Product | Active comparator | Drug: Acyclovir 5 percent (Reference)acyclovir cream |
| Placebo Product | Placebo comparator | Drug: Placebo creamPlacebo cream |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acyclovir 5 percent (Perrigo)Also: Perrigo product | Drug | Test Product |
| Acyclovir 5 percent (Reference)Also: Reference Listed Drug Product | Drug | Reference Product |
| Placebo cream | Drug | Placebo Product |
Primary outcome
Lesion Healing
Time frame: up to 21 days
Time to complete healing of lesions measured in hours from the time of first dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Herpes Labialis
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acyclovir 5 percent (Perrigo) and Acyclovir 5 percent (Reference) in people with Herpes Labialis, run by Padagis LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion Healing (time frame: up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.