Double-Blind, Placebo-Controlled Clinical Trial Evaluating Benzoyl Peroxide for Preventing Recurrence of HSV-1 Outbreaks With Rescue Crossover Option
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to First Recurrence of HSV-1 Outbreaks Within 6 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Active Treatment
10% Benzoyl Peroxide topically applied
干预措施: Benzoyl Peroxide 10% Bar (Drug)
Placebo Arm
Placebo applied topically
干预措施: Placebo (Other)
结局指标
主要结局
Time to First Recurrence of HSV-1 Outbreaks Within 6 Months
时间窗: 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.
次要结局
未报告次要终点
研究者
Greg Bew
Clinical Research Coordinator
Erroll McCoy