Evaluating Benzoyl Peroxide for Preventing Recurrence of HSV-1 Outbreaks With Rescue Crossover Option
brief 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.
detailed description
This is a randomized, double-blind, placebo-controlled clinical trial investigating the effectiveness of topical Benzoyl Peroxide 10% cream in preventing the recurrence of oral lesions (cold sores) caused by Herpes Simplex Virus Type 1 (HSV-1). The study is designed as a small-scale, pilot clinical trial conducted entirely via telehealth appointments, with treatment and placebo creams shipped directly to enrolled participants.
Participants aged 18-65 with a documented history of at least two HSV-1 outbreaks per year will be enrolled and randomized into two groups:
* \*\*Active Treatment Group\*\*: Receives topical Benzoyl Peroxide 10% cream. * \*\*Placebo Group\*\*: Receives an identical topical cream formulation without the active ingredient.
All participants will be instructed to apply the assigned topical cream twice daily (morning and evening) at the onset of HSV-1 symptoms for a minimum of five days, continuing until lesions fully resolve or up to a maximum of 14 days.
The primary objective of this clinical trial is to evaluate the efficacy of Benzoyl Peroxide 10% cream in extending the time until the recurrence of HSV-1 outbreaks within a 6-month follow-up period compared to placebo.
Secondary outcomes include:
* Evaluating the frequency of HSV-1 recurrences within 6 months. * Measuring the severity and duration of lesions and associated pain. * Determining participant satisfaction and overall treatment acceptability. * Assessing the effect of lesion anatomical location on recurrence patterns.
A unique aspect of this trial is the inclusion of a \*\*rescue crossover procedure\*\*, where participants initially randomized to placebo who experience a confirmed recurrence at the previously treated site will be provided Benzoyl Peroxide 10% cream, ensuring ethical access to potentially effective treatment.
To ensure unbiased trial conduct and data integrity, oversight measures have been implemented, including:
* Independent Clinical Research Coordinator (with no financial interest) responsible for auditing data accuracy, protocol adherence, and regulatory compliance. * Supervising Physician (with no financial interest) providing clinical oversight and quality assurance of trial activities conducted by the Principal Investigator.
official title
Double-Blind, Placebo-Controlled Clinical Trial Evaluating Benzoyl Peroxide for Preventing Recurrence of HSV-1 Outbreaks With Rescue Crossover Option