A Phase 2, Multi-site, Randomized, Double-blind, Vehicle-controlled Study of the Efficacy and Safety of Squaric Acid Dibutyl Ester (SADBE) in Subjects With Recurrent Herpes Labialis - Single Versus Two-dose Arm Application
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Squarex, LLC
- 入组人数
- 139
- 试验地点
- 5
- 主要终点
- Days to Next Herpes Labialis (Cold Sore) Episode From 43 Days After the First Dose up to 121 Days After the First Dose
研究概览
简要总结
This study evaluates the safety and efficacy of SADBE in the prevention of recurrent herpes labialis in adults. Two-thirds of the participants will receive a SADBE solution, while the other third will receive only the vehicle as a placebo control. The solutions will be administered topically to the patient's arms. The study will compare a single-arm application versus a two-arm application versus two placebo doses on the arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of herpes labialis, which may be made at the screening visit based on the patient's self-reported history of symptoms. An active herpes labialis outbreak at the time of entry into the clinical trial will neither be required nor will be an exclusion criteria.
- •Self report having four or more episodes of herpes labialis in the past 12 months
排除标准
- •People that have had treatment with anti viral therapy within 2 weeks before sensitization dose.
- •Pregnant or lactating females.
- •Current or recurrent non-herpetic infection or any underlying condition that may predispose to infection or anyone who has been admitted to the hospital due to bacteremia, pneumonia or any other serious infection.
- •Therapy with glucocorticoid or immunosuppressants at time of recruitment or within past 4 weeks, except for inhaled corticosteroids for asthma or topical steroids in sites other than face.
- •History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers)
- •History of organ transplantation
- •HIV-positive status determined by history at screening or known history of any other immunosuppressive disease.
- •Severe co-morbidities (diabetes mellitus requiring insulin, CHF (EF<50% at baseline will be exclusionary) MI, CVA or TIA within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease
- •History of exposure to squaric acid or squaric acid dibutyl ester.
- •Known hypersensitivity to DMSO
- •Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
- •Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit.
- •Previous or current participation in a clinical trial of SADBE to treat herpes labialis.
研究组 & 干预措施
One SADBE application
Patient will receive a topical 2% SADBE sensitization dose applied to the patient's upper arm. Three weeks after topical sensitization dose patient will receive topical placebo applied to the patient's upper arm.
干预措施: SADBE (Drug)
One SADBE application
Patient will receive a topical 2% SADBE sensitization dose applied to the patient's upper arm. Three weeks after topical sensitization dose patient will receive topical placebo applied to the patient's upper arm.
干预措施: Placebo (Other)
Two SADBE applications
Patient will receive a topical 2% SADBE sensitization dose applied to the patient's upper arm. A 0.5% SADBE intensification dose will be applied to the patient's upper arm 3 weeks after sensitization dose.
干预措施: SADBE (Drug)
Placebo application (DMSO only-No SADBE)
Patient will receive a topical placebo (vehicle-DMSO) dose applied to the patient's upper arm. A topical placebo (vehicle-DMSO) follow up dose will be applied to the patient's upper arm 3 weeks after the first placebo dose dose.
干预措施: Placebo (Other)
结局指标
主要结局
Days to Next Herpes Labialis (Cold Sore) Episode From 43 Days After the First Dose up to 121 Days After the First Dose
时间窗: 43 - 121 days after the first dose
The number of days until a patient reports his or her first new herpes labialis episode from 43 - 121 days following the first dose
次要结局
- Number of Outbreaks Beginning 43 Days After the First Dose up to 12 Months(From day 43 after the first dose up to 12 months)