NCT03977792Unknown2 期
A Randomized, Open Label, Non-inferiority Study to Compare the Safety and Efficacy of BOR15001L7 to Docosanol 10% in Patients With Recurrent Herpes Labialis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 164
- 主要终点
- The mean change of healing time
研究概览
简要总结
BOR15001L7 is a natural product. The primary objective of this study is to demonstrate its non-inferiority to docosanol 10% based on the healing time of cold sores in patients with recurrent herpes labialis.
详细描述
Secondary objectives are to:
- Evaluate the efficacy of BOR1500L7 on:
- The reduction of ulcerative lesions rates following the prodromal stage;
- The extension of the delay prior to first ulcerative lesions occurence following the prodromal stage;
- The decrease of cumulative ulcerative lesions dimensions during papule, vesicles, ulcers/soft and hard crust stages;
- The decrease of symptoms intensity (pain, tingling, itching, burning sensation) during prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages;
- The reduction of symptoms duration (pain, tingling, itching, burning sensation) during the prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages in subjects with recurrent herpes labialis;
- Evaluate the safety and tolerability of BOR15001L7 in subjects with recurrent herpes labialis
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
- None
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
- •Provide signed informed consent and willing to comply with study-related procedures;
- •Males and females ≥18 years of age at screening;
- •Diagnosed with recurrent herpes labialis, defined as showing at least 2 episodes of infections per year;
- •Willing to avoid, during the treatment phase, the use of anti-inflammatory, anti-herpetic, antibiotic and antiviral agents as well as steroids or other natural products that would interfere with the immune system response (exception: only the use of valacyclovir will be permitted, if prescribed);
- •Willing to avoid, during the treatment phase, the use of cosmetic products (ex. cream, make-up, etc.) at areas close to the infected region.
排除标准
- •Patients with skin disease affecting the peribuccal region (eczema, psoriasis, dermatitis, etc.);
- •Patients with herpes labialis occurring within 14 days prior to screening;
- •Patients known for allergies or intolerance to drug and comparator ingredients, or any cream used to treat skin conditions;
- •Treatment with an investigational product or biological agent or device within 30 days or five half˗lives, whichever is longer.
- •Any other condition, which, in the opinion of the investigator or the sponsor would make the patient unsuitable for inclusion, or could interfere with the conduct of the study.
研究组 & 干预措施
Experimental treatment
Experimental
Subjects treated with BOR15001L7.
All subjects will be randomized 1:1 (BOR15001L7:docosanol 10%) to receive either BOR15001L7 or docosanol 10%.
干预措施: BOR15001L7 (Drug)
Comparator treatment
Active Comparator
Subjects treated with Docosanol 10%.
All subjects will be randomized 1:1 (BOR15001L7:docosanol 10%) to receive either BOR15001L7 or docosanol 10%.
干预措施: Docosanol Cream 10% (Drug)
结局指标
主要结局
The mean change of healing time
时间窗: Day 1 to 12
次要结局
- The change in lesion rates following the prodromal stage(Day 1 to 12)
- The percentage change in dimensions (mm) of lesions at papule, vesicles and ulcers/soft crust, hard crust stages(Day 1 to 12)
- Safety and tolerability measured by the Incidence of Treatment-Emergent Adverse Events [Side-effects](Day 1 to 12)
- The mean change in delays (hours) between the prodromal stage and the first visible occurence of lesions(Day 1 to 12)
- The percentage of patients that demonstrated a change in intensity of drug-related symptoms (pain, tingling, itching, burning sensation) at papule, vesicles and ulcers/soft crust, hard crust stages(Day 1 to 12)
- The mean change in duration (hours) of drug-related symptoms (pain, tingling, itching, burning sensation) at papule, vesicles and ulcers/soft crust, hard crust stages(Day 1 to 12)
- The percentage change in number of lesions at papule, vesicles and ulcers/soft crust, hard crust stages(Day 1 to 12)
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