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Safety, Tolerability and Therapeutic Efficacy of Topical ZEP-3 Ointment (1.0%) for the Treatment of Cold Sores

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ClinicalTrials.gov Identifier: NCT02483182
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Shulov Innovate for Science Ltd. 2012

Brief 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.

Condition or disease Intervention/treatment Phase
Herpes Labialis Drug: ZEP-3 ointment 1.0% Drug: Acyclovir cream 5% Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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).
Study Start Date : September 2015
Actual Primary Completion Date : June 24, 2018
Actual Study Completion Date : June 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cold Sores

Arm Intervention/treatment
Experimental: ZEP-3 ointment 1.0%
Topical administration
Drug: ZEP-3 ointment 1.0%
Active Comparator: Acyclovir cream 5%
Topical administration
Drug: Acyclovir cream 5%
Other Name: Zovirax




Primary Outcome Measures :
  1. Clinician-assessed "Time to healing" [ Time Frame: Up to 14 days ]

Secondary Outcome Measures :
  1. Time for Herpes labialis recurrences [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Prior to enrollment in this study, candidates must meet ALL of the following inclusion criteria:

  1. Patients suffering from recurrent Herpes labialis with history of at least 3 cold sores recurrences during the previous 12 months.
  2. Participants, either male or female are between 18 and 75 years of age.
  3. 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.

  4. Patients with previous Herpes labialis episode must be healed for at least 14 days before baseline visit
  5. Patients with no history of reaction to topical products.
  6. Female subjects of childbearing potential must have a negative pregnancy test at screening and agree to use a proper contraceptive method during the study.
  7. Participant understands the nature of the procedure and is willing and able to comply with all requirement of the protocol.
  8. Patient is willing and able to provide written informed consent prior to any study procedure.

Exclusion Criteria:

  1. Subject has abnormal skin conditions or significant facial hair at or near the investigational area
  2. Subject has any body piercing in or around the area ordinarily affected by cold sores.
  3. Subjects with a history of cardiac abnormalities.
  4. Subject has a recent history of renal dysfunction or serious hepatic disease
  5. Subject has an active malignancy or immunodeficient disease
  6. 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.
  7. Subject requires chronic use of immunomodifying drugs or topical steroids on or near the face.
  8. Subject requires chronic use of anti-viral medication.
  9. Subject requires chronic use of analgesics, pain medication or non-steroidal anti inflammatory agents (NSAIDs).
  10. History of allergic or adverse response to acyclovir, or any related anti-viral drug.
  11. Subject has had an infection with HSV-1 isolates know to be resistant to acyclovir, valacyclovir, famciclovir, or ganciclovir.
  12. Subject has had a herpes vaccine.
  13. Females during pregnancy, lactation or breastfeeding.
  14. Subject has a history of alcoholism or drug abuse within the preceding 12 months.
  15. Subject is currently enrolled in another clinical trial involving the use of a drug and/or a device.
  16. Any history which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.
  17. Subjects with immune deficiency conditions including acquired immune deficiency.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483182


Locations
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Israel
Dermatology out-patients clinic, Lev Hayasmin MC
Netanya, Israel
Sponsors and Collaborators
Shulov Innovate for Science Ltd. 2012
Investigators
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Principal Investigator: Shemer Avner, Prof., M.D. Dermatology out-patients clinic, Lev Hayasmin - Medical center, Natanya, ISRAEL

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Responsible Party: Shulov Innovate for Science Ltd. 2012
ClinicalTrials.gov Identifier: NCT02483182     History of Changes
Other Study ID Numbers: ZEP - 002 - IL
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: April 2018

Keywords provided by Shulov Innovate for Science Ltd. 2012:
Herpes labialis, Cold sores, ZEP-3 ointment

Additional relevant MeSH terms:
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Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases
Acyclovir
Antiviral Agents
Anti-Infective Agents