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

ConditionHSV
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGreg Bew

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Benzoyl Peroxide 10% Bar

    Drug

    Active ingredient for drug included. Blind identification by package number

  • Placebo

    Other intervention

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Active TreatmentExperimental treatment 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to First Recurrence of HSV-1 Outbreaks Within 6 Months

The primary outcome measure is the duration of time (measured in days) from initial treatment application until the participant experiences the first confirmed recurrence of an HSV-1 lesion. Recurrence is confirmed through telehealth video consultation and visual verification by the study team. The maximum observation period for each participant is 6 months following initial treatment. The effectiveness of topical Benzoyl Peroxide (10%) versus placebo in prolonging recurrence-free intervals will be evaluated using Kaplan-Meier analysis.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Greg Bew

Lead sponsor

Erroll McCoy

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: