Herpes LabialisPhase 2NCT02483182
Safety, Tolerability and Therapeutic Efficacy of Topical ZEP-3 Ointment (1.0%) for the Treatment of Cold Sores
A Phase 2 study testing ZEP-3 ointment 1.0% and Acyclovir cream 5% in people with Herpes Labialis, run by Shulov Innovate for Science Ltd. 2012 at 1 site in Israel.
Trial summary
This is a phase II, prospective, randomized, double-blind, parallel group, acyclovir-controlled clinical study to evaluate the safety, tolerability and preliminary therapeutic efficacy of ZEP-3 ointment 1.0% for the treatment of cold sores (Herpes labialis), following five consecutive treatment days with five times… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Herpes Labialis
- What is being tested?
- ZEP-3 ointment 1.0% and Acyclovir cream 5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2015to 24 Jun 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior to enrollment in this study, candidates must meet ALL of the following inclusion criteria:
- Patients suffering from recurrent Herpes labialis with history of at least 3 cold sores recurrences during the previous 12 months.
- Participants, either male or female are between 18 and 75 years of age.
- Patients arrive at the clinic with any symptom of an acute Herpes labialis episode.
- Or, patients arrive at the clinic within 48 hours of treatment initiation for a recurrent Herpes labialis episode.
- Patients with previous Herpes labialis episode must be healed for at least 14 days before baseline visit
Show all 10Show fewer
- Patients with no history of reaction to topical products.
- Female subjects of childbearing potential must have a negative pregnancy test at screening and agree to use a proper contraceptive method during the study.
- Participant understands the nature of the procedure and is willing and able to comply with all requirement of the protocol.
- Patient is willing and able to provide written informed consent prior to any study procedure.
Who cannot join
- Subject has abnormal skin conditions or significant facial hair at or near the investigational area
- Subject has any body piercing in or around the area ordinarily affected by cold sores.
- Subjects with a history of cardiac abnormalities.
- Subject has a recent history of renal dysfunction or serious hepatic disease
- Subject has an active malignancy or immunodeficient disease
- Subject who is unwilling to stop using topical medical, OTC, cosmetics or facial skin care products in or around the oral area during the study period.
Show all 17Show fewer
- Subject requires chronic use of immunomodifying drugs or topical steroids on or near the face.
- Subject requires chronic use of anti-viral medication.
- Subject requires chronic use of analgesics, pain medication or non-steroidal anti inflammatory agents (NSAIDs).
- History of allergic or adverse response to acyclovir, or any related anti-viral drug.
- Subject has had an infection with HSV-1 isolates know to be resistant to acyclovir, valacyclovir, famciclovir, or ganciclovir.
- Subject has had a herpes vaccine.
- Females during pregnancy, lactation or breastfeeding.
- Subject has a history of alcoholism or drug abuse within the preceding 12 months.
- Subject is currently enrolled in another clinical trial involving the use of a drug and/or a device.
- Any history which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.
- Subjects with immune deficiency conditions including acquired immune deficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Randomized, Double-Blind, Parallel Group, Acyclovir-Controlled Study to Evaluate ZEP-3 Ointment for the Treatment of Cold Sores (Herpes Labialis).
This is a phase II, prospective, randomized, double-blind, parallel group, acyclovir-controlled clinical study to evaluate the safety, tolerability and preliminary therapeutic efficacy of ZEP-3 ointment 1.0% for the treatment of cold sores (Herpes labialis), following five consecutive treatment days with five times daily topical administration.
Read the detailed description
The primary endpoint of this study are:
- "Time to healing" - Clinician-assessed duration in days of herpes labialis episode.
- Patient-assessed duration and intensity of pain by Visual Analog Scale (VAS).
- Safety and tolerability following five consecutive treatment days with five times daily topical administration.
The secondary endpoints of this study are:
- Proportion of subjects with non - ulcerative herpes lesion.
- Time for herpes labialis recurrences
Subject safety will be assessed following treatment by ZEP-3 ointment 1.0% or acyclovir cream 5% treatment, using measurements of the following variables:
- Physical examination,
- Vital Signs (HR, BP, Body temperature),
- Adverse events recording and
- Concomitant medications
- Conditions
- Herpes Labialis
- Being tested
- ZEP-3 ointment 1.0%, Acyclovir cream 5%
- Keywords
- Herpes labialis, Cold sores, ZEP-3 ointment
- Medical subject headings
- Herpes Labialis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZEP-3 ointment 1.0%Drug
Acyclovir cream 5%Drug
Also called Zovirax
| Study group | Role | What they receive |
|---|---|---|
| ZEP-3 ointment 1.0% | Experimental | Topical administration Receives: Drug: ZEP-3 ointment 1.0% |
| Acyclovir cream 5% | Active comparator | Topical administration Receives: Drug: Acyclovir cream 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-assessed "Time to healing"
Measured: Up to 14 days
Secondary outcomes (1)
Time for Herpes labialis recurrences
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startSep 2015
- Primary completion24 Jun 2018
- Study completion24 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shulov Innovate for Science Ltd. 2012
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shemer Avner, Prof., M.D., Principal investigator, Dermatology out-patients clinic, Lev Hayasmin - Medical center, Natanya, ISRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483182
- Sponsor's protocol ID
- ZEP - 002 - IL
- Status last verified
- Apr 2018
- First submitted
- 24 Jun 2015
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Parallel Group, Acyclovir-Controlled Study to Evaluate ZEP-3 Ointment for the Treatment of Cold Sores (Herpes Labialis).
- ClinicalTrials.gov ID
- NCT02483182
- Acronym / sponsor ID
- ZEP - 002 - IL
- Conditions
- Herpes Labialis
- Keywords
- Herpes labialis, Cold sores, ZEP-3 ointment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Shulov Innovate for Science Ltd. 2012Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- 24 Jun 2018 (actual)
- Study completion
- 24 Jun 2018 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, prospective, randomized, double-blind, parallel group, acyclovir-controlled clinical study to evaluate the safety, tolerability and preliminary therapeutic efficacy of ZEP-3 ointment 1.0% for the treatment of cold sores (Herpes labialis), following five consecutive treatment days with five times daily topical administration.
Detailed description
The primary endpoint of this study are:
- "Time to healing" - Clinician-assessed duration in days of herpes labialis episode.
- Patient-assessed duration and intensity of pain by Visual Analog Scale (VAS).
- Safety and tolerability following five consecutive treatment days with five times daily topical administration.
The secondary endpoints of this study are:
- Proportion of subjects with non - ulcerative herpes lesion.
- Time for herpes labialis recurrences
Subject safety will be assessed following treatment by ZEP-3 ointment 1.0% or acyclovir cream 5% treatment, using measurements of the following variables:
- Physical examination,
- Vital Signs (HR, BP, Body temperature),
- Adverse events recording and
- Concomitant medications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZEP-3 ointment 1.0% | Experimental | Drug: ZEP-3 ointment 1.0%Topical administration |
| Acyclovir cream 5% | Active comparator | Drug: Acyclovir cream 5%Topical administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Prior to enrollment in this study, candidates must meet ALL of the following inclusion criteria:
- Patients suffering from recurrent Herpes labialis with history of at least 3 cold sores recurrences during the previous 12 months.
- Participants, either male or female are between 18 and 75 years of age.
- Patients arrive at the clinic with any symptom of an acute Herpes labialis episode.
- Or, patients arrive at the clinic within 48 hours of treatment initiation for a recurrent Herpes labialis episode.
Key exclusion criteria (17 listed)
- Subject has abnormal skin conditions or significant facial hair at or near the investigational area
- Subject has any body piercing in or around the area ordinarily affected by cold sores.
- Subjects with a history of cardiac abnormalities.
- Subject has a recent history of renal dysfunction or serious hepatic disease
- Subject has an active malignancy or immunodeficient disease
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 |
|---|---|---|
| ZEP-3 ointment 1.0% | Drug | ZEP-3 ointment 1.0% |
| Acyclovir cream 5%Also: Zovirax | Drug | Acyclovir cream 5% |
Primary outcome
Clinician-assessed "Time to healing"
Time frame: Up to 14 days
1 secondary outcome
Time for Herpes labialis recurrences
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
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.
Shemer Avner, Prof., M.D. principal investigator
Dermatology out-patients clinic, Lev Hayasmin - Medical center, Natanya, ISRAEL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZEP-3 ointment 1.0% and Acyclovir cream 5% in people with Herpes Labialis, run by Shulov Innovate for Science Ltd. 2012 at 1 site in Israel.
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 10 inclusion and 17 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 30 May 2019. 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 Israel. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinician-assessed "Time to healing" (time frame: Up to 14 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 30 May 2019.