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Double-blind, Vehicle-controlled Study of the Efficacy and Safety of SADBE in Subjects With Recurrent Herpes Labialis

NCT02965781 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2021-11-02

Study results available
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Summary

This study evaluates the safety and efficacy of SADBE in the prevention of recurrent herpes labialis in adults. Two-thirds of the participants will receive a SADBE solution, while the other third will receive only the vehicle as a placebo control. The solutions will be administered topically to the patient's arms. The study will compare a single-arm application versus a two-arm application versus two placebo doses on the arm.

Conditions

  • Herpes Labialis
  • Cold Sore

Interventions

DRUG

SADBE

Topical solution

OTHER

Placebo

Topical solution

Sponsors & Collaborators

  • Squarex, LLC

    lead INDUSTRY

Principal Investigators

  • Hugh McTavish, PhD, JD · Squarex, LLC

  • Thomas D Horn, MD · Squarex, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-12-20
Completion
2018-12-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02965781 on ClinicalTrials.gov