A Phase 2 interventional study of Benzoyl Peroxide 10% Bar and Placebo in HSV, sponsored by Greg Bew. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-05.
Sponsored by Greg Bew · Phase 2, Interventional, and Treatment
Here's a clear, concise, and accurate **brief summary** suitable for your ClinicalTrials.gov PRS submission:
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.
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:
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:
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:
Results from this trial aim to inform the potential efficacy and safety profile of Benzoyl Peroxide as a topical therapy for HSV-1 recurrence prevention, potentially supporting future FDA regulatory submissions or larger-scale clinical trials.
166 studies on the registry are indexed under Herpes Simplex; 12 are open to participants now.
This study's planned enrollment of 100 is above the median of 66 across 113 interventional studies indexed under Herpes Simplex.
Browse Herpes Simplex studies →This is the only study on the registry with Greg Bew as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adults aged 18-65 years, inclusive.
Documented history of at least two HSV-1 outbreaks per year.
Ability and willingness to participate fully via telehealth (including video visits).
Must provide to participate in the trial.
Ability to comply with the trial protocol, including symptom reporting, topical cream application, and follow-up telehealth appointments.
Exclusion Criteria:
Currently pregnant or breastfeeding, or plans to become pregnant during the study period.
Known allergy or sensitivity to benzoyl peroxide or similar topical agents.
Current participation in another clinical trial involving topical treatments.
Medical conditions or skin conditions that could significantly interfere with topical treatment application or safety assessment.
Inability to effectively participate in telehealth visits or use video-based symptom verification.
Participants who, in the opinion of the investigator, are unlikely to comply fully with trial requirements or complete the 6-month follow-up period.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10% Benzoyl Peroxide topically applied
Drug: Benzoyl Peroxide 10% Bar
Placebo applied topically
Other: Placebo
Active ingredient for drug included. Blind identification by package number
Placebo that looks like active treatment, blinded but available to ID via package number
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
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Benzoyl Peroxide