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Evaluating Benzoyl Peroxide for Preventing Recurrence of HSV-1 Outbreaks With Rescue Crossover Option

NCT07032649 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-05

No results posted yet for this study

Summary

Here's a clear, concise, and accurate \*\*brief summary\*\* suitable for your ClinicalTrials.gov PRS submission:

* Brief Summary:

This randomized, double-blind, placebo-controlled clinical trial evaluates the effectiveness of topical Benzoyl Peroxide (10%) in preventing recurrent oral lesions caused by Herpes Simplex Virus Type 1 (HSV-1). Participants who experience frequent HSV-1 outbreaks will be randomly assigned to either Benzoyl Peroxide or placebo treatment. The trial will be conducted via telehealth visits, with treatment provided remotely. The primary objective is to determine whether Benzoyl Peroxide significantly delays or prevents HSV-1 lesion recurrence compared to placebo. Secondary outcomes include evaluating recurrence frequency, lesion severity, healing duration, and participant satisfaction. The trial also incorporates a rescue crossover step, allowing placebo-group participants who experience recurrence to receive active treatment. Results from this pilot study will inform the potential use of Benzoyl Peroxide as a novel, accessible topical treatment option for recurrent HSV-1 outbreaks.

Conditions

  • HSV

Interventions

DRUG

Benzoyl Peroxide 10% Bar

Active ingredient for drug included. Blind identification by package number

OTHER

Placebo

Placebo that looks like active treatment, blinded but available to ID via package number

Sponsors & Collaborators

  • Greg Bew

    lead INDUSTRY

Principal Investigators

  • David Dinn, DMSc · Erroll McCoy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-01-31
Completion
2027-07-31
FDA Drug
Yes

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 NCT07032649 on ClinicalTrials.gov