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 range18 Years – 75 Years
SexALL
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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.
✓. 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.