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

NCT07032649 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: EM202501
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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• 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.

Conditions

HSV

Keywords

HSV; HSV-1; HSV suppression; Herpes

Outcome Measures

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.

  6 months

Study Arms (2)

Active Treatment

EXPERIMENTAL

10% Benzoyl Peroxide topically applied

Drug: Benzoyl Peroxide 10% Bar

Placebo Arm

PLACEBO COMPARATOR

Placebo applied topically

Other: Placebo

Interventions

Benzoyl Peroxide 10% Bar DRUG

Active ingredient for drug included. Blind identification by package number

Active Treatment

Placebo OTHER

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

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Greg Bew: lead

Study Sites (1)

Zoom Health, Telehealth Only

Evans, Georgia, 30809, United States

Location

MeSH Terms

Conditions

Herpes Simplex

Interventions

Benzoyl Peroxide; Receptors, Catecholamine

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Receptors, Biogenic Amine; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, G-Protein-Coupled; Receptors, Neurotransmitter

Study Officials

• David Dinn, DMSc

  Erroll McCoy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Greg Bew, MS

CONTACT

833-203-4773; business@errollmccoy.com

Keri Fischer, MS

CONTACT

kfischer@errollmccoy.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Coordinator

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)