HSVPhase 2NCT07032649
Evaluating Benzoyl Peroxide for Preventing Recurrence of HSV-1 Outbreaks With Rescue Crossover Option
A Phase 2 study testing Benzoyl Peroxide 10% Bar in people with HSV, run by Greg Bew at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HSV
- What is being tested?
- Benzoyl Peroxide 10% Bar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 informed consent to participate in the trial.
- Ability to comply with the trial protocol, including symptom reporting, topical cream application, and follow-up telehealth appointments.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Keri Fischer, MS contact
United States1 site
Zoom Health, Telehealth Only
Evans, Georgia, 30809
Greg Bew, MS, 833-203-4773, gbew@errollmccoy.com
About this study
Official title: Double-Blind, Placebo-Controlled Clinical Trial Evaluating Benzoyl Peroxide for Preventing Recurrence of HSV-1 Outbreaks With Rescue Crossover Option
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.
Read the 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.
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.
- Conditions
- HSV
- Being tested
- Benzoyl Peroxide 10% Bar, Placebo
- Keywords
- HSV, HSV-1, HSV suppression, Herpes
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzoyl Peroxide 10% BarDrug
Active ingredient for drug included. Blind identification by package number
PlaceboOther
Placebo that looks like active treatment, blinded but available to ID via package number
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | 10% Benzoyl Peroxide topically applied Receives: Drug: Benzoyl Peroxide 10% Bar |
| Placebo Arm | Placebo comparator | Placebo applied topically Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HSVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Greg Bew
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Greg Bew, Erroll McCoy
- Investigators
- David Dinn, DMSc, Principal investigator, Erroll McCoy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032649
- Sponsor's protocol ID
- EM202501
- Status last verified
- Aug 2025
- First submitted
- 16 Jun 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled Clinical Trial Evaluating Benzoyl Peroxide for Preventing Recurrence of HSV-1 Outbreaks With Rescue Crossover Option
- ClinicalTrials.gov ID
- NCT07032649
- Acronym / sponsor ID
- EM202501
- Conditions
- HSV
- Keywords
- HSV, HSV-1, HSV suppression, Herpes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Greg BewIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Drug: Benzoyl Peroxide 10% Bar10% Benzoyl Peroxide topically applied |
| Placebo Arm | Placebo comparator | Other: PlaceboPlacebo applied topically |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 informed consent to participate in the trial.
- Ability to comply with the trial protocol, including symptom reporting, topical cream application, and follow-up telehealth appointments.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benzoyl Peroxide 10% BarActive ingredient for drug included. Blind identification by package number | Drug | Active Treatment |
| PlaceboPlacebo that looks like active treatment, blinded but available to ID via package number | Other | Placebo Arm |
Primary outcome
Time to First Recurrence of HSV-1 Outbreaks Within 6 Months
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keri Fischer, MS contact
David Dinn, DMSc principal investigator
Erroll McCoy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Benzoyl Peroxide 10% Bar in people with HSV, run by Greg Bew at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Greg Bew, MS (833-203-4773, business@errollmccoy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Recurrence of HSV-1 Outbreaks Within 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.