Safety, Tolerability and Therapeutic Efficacy of Topical ZEP-3 Ointment (1.0%) for the Treatment … (NCT02483182) | Clinical Trial Compass
CompletedPhase 2
Safety, Tolerability and Therapeutic Efficacy of Topical ZEP-3 Ointment (1.0%) for the Treatment of Cold Sores
Israel210 participantsStarted 2015-09
Plain-language 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 daily topical administration.
Who can participate
Age range
18 Years – 75 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
. 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.
. Patients with previous Herpes labialis episode must be healed for at least 14 days before baseline visit
. 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.
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.
. 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.
Exclusion criteria
. 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.
. Subject requires chronic use of immunomodifying drugs or topical steroids on or near the face.
. Subject requires chronic use of anti-viral medication.