NCT02483182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2018

Completed
Last Updated

May 30, 2019

Status Verified

April 1, 2018

Enrollment Period

2.8 years

First QC Date

June 24, 2015

Last Update Submit

May 28, 2019

Conditions

Herpes Labialis

Keywords

Herpes labialis, Cold sores, ZEP-3 ointment

Outcome Measures

Primary Outcomes (1)

  • Clinician-assessed "Time to healing"

    Up to 14 days

Secondary Outcomes (1)

  • Time for Herpes labialis recurrences

    12 months

Study Arms (2)

ZEP-3 ointment 1.0%

EXPERIMENTAL

Topical administration

Drug: ZEP-3 ointment 1.0%

Acyclovir cream 5%

ACTIVE COMPARATOR

Topical administration

Drug: Acyclovir cream 5%

Interventions

ZEP-3 ointment 1.0%DRUG
ZEP-3 ointment 1.0%
Acyclovir cream 5%DRUG
Also known as: Zovirax
Acyclovir cream 5%

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology out-patients clinic, Lev Hayasmin MC

Netanya, Israel

Location

MeSH Terms

Conditions

Herpes Labialis

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Herpes SimplexHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralLip DiseasesMouth DiseasesStomatognathic DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Shemer Avner, Prof., M.D.

    Dermatology out-patients clinic, Lev Hayasmin - Medical center, Natanya, ISRAEL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2015

First Posted

June 26, 2015

Study Start

September 1, 2015

Primary Completion

June 24, 2018

Study Completion

June 24, 2018

Last Updated

May 30, 2019

Record last verified: 2018-04

Locations

IL(1)