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

Condition(s) studied

Investigational drug(s) / intervention(s)

Benzoyl Peroxide 10% Bar: Active ingredient for drug included. Blind identification by package number

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

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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)