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

Part of paid clinical trials in Evans, Georgia.

Sponsor
Greg Bew
Study ID
NCT07032649
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • HSV

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Benzoyl Peroxide 10% Bar — DRUG
    Active ingredient for drug included. Blind identification by package number
  • Placebo — OTHER
    Placebo that looks like active treatment, blinded but available to ID via package number

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
Aug 2025
Primary completion
Jan 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Treatment
    10% Benzoyl Peroxide topically applied
  • Placebo Comparator: Placebo Arm
    Placebo applied topically

Primary Outcome Measure

Time to First Recurrence of HSV-1 Outbreaks Within 6 Months [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Zoom Health, Telehealth OnlyEvansGeorgia30809
Greg Bew, MS
833-203-4773

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