A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of NB-001 Treatment of Recurrent Herpes Labialis
试验速览
- 阶段
- 3 期
- 入组人数
- 362
- 试验地点
- 8
- 主要终点
- Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator.
研究概览
简要总结
This is a study to test the hypothesis that time to healing of a cold sore will be lower in the active treatment arm of the study when compared to the vehicle (placebo). Subjects with a history of cold sores will be enrolled and administered active treatment or placebo in a blinded manner. Subjects will then be followed to assess time to healing.
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
- 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
- •Be a healthy man or woman 18 years of age or older. Women who are pregnant, lactating or may become pregnant may (at the investigator's discretion) be included in the study;
- •Have recurrent herpes labialis as defined by a history of three (3) or more cold sore recurrences on the lips and/or skin surrounding the lips in the previous year. The majority of their cold sore recurrences proceeded by a well-defined history of prodromal symptoms including redness, pain, burning, tingling, itching, swelling or a tight sensation of the lip at the site of the outbreak;
- •Be willing to refrain from using systemic or topical antiviral agents or systemic corticosteroids within 4 weeks prior to study drug administration and for the duration of the cold sore recurrence;
- •Be willing to refrain from using any topical pharmaceutical or cosmetic products other than the study medication in or around the nasal and perioral areas for the duration of the cold sore recurrence;
- •Be willing to refrain from participation in another clinical trial;
- •Be willing and able to use phone or internet to obtain the combination to unlock their study medication kit;
- •Be able to read and write in English and understand and comply with the protocol requirements;
- •Be able to give informed consent and have signed a written informed consent form.
排除标准
- •Known hypersensitivity to one of the drug ingredients, including soybean oil, polysorbate (Tween), alcohol, EDTA, or cetylpyridinium chloride (found in some mouthwashes and lozenges);
- •Severe chronic illness including renal failure, severe respiratory or cardiac disease, chronic infections, immunodeficiency syndrome, uncontrolled diabetes mellitus or untreated severe thyroid disease;
- •Received (within the last 6 months) or receiving chemotherapy;
- •Significant skin disease on the face (such as atopic dermatitis, cystic acne, severe rosacea, eczema, psoriasis or other chronic vesiculobullous disorders) or lesions, wounds, abrasions, piercings, tattoos, irritation or other skin conditions on or around the nasal and perioral areas that would interfere with the treatment or assessment of the primary lesion complex. Subjects with mild controlled psoriasis, eczema, acne or dermatitis or other conditions may be included if the condition does not interfere with the ability to evaluate a herpes labialis lesion or local skin irritation;
- •Previously received herpes vaccine;
- •Active alcohol or drug abuse;
- •Prior randomization into any NanoBio study;
- •Any condition that would potentially make them unable to participate for the entire trial period;
- •Known allergies to topical creams, ointments or other topical medications.
研究组 & 干预措施
NB-001 (0.3%)
NB-001 is an oil-in-water emulsion composed of nanometer-sized, positively charged droplets (average particle size = 180nm). NB-001 is composed of highly refined soybean oil, purified water, ethanol, edetate disodium dihydrate (EDTA) and two surfactants: polysorbate (Tween) 20 and cetylpyridinium chloride (CPC).
干预措施: NB-001 (0.3%) (Drug)
Vehicle
NB-001 is an oil-in-water emulsion composed of nanometer-sized, positively charged droplets (average particle size = 180nm). NB-001 is composed of highly refined soybean oil, purified water, ethanol, edetate disodium dihydrate (EDTA) and one surfactant: polysorbate (Tween) 20.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to healing of the primary lesion complex (in days or fraction thereof) as assessed by the investigator.
时间窗: Time to healing will be assessed from treatment onset to resolution of symptoms (maximum of 16 days)
Time to healing is the time from receiving the combination to unlock the medication and begin treatment to investigator assessed healing.
次要结局
- Proportion of subjects in whom the primary lesion complex does not progress beyond the Papule/Edema Stage(Proportion of subjects in whom the primary lesion complex does not progress will be assessed from treatment onset to resolution of symptoms (maximum of 16 days))