A Double-Blind, Randomized, Placebo-Controlled, Safety, Tolerability, and Efficacy Trial of a Novel Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) For The Treatment of Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 5
- 主要终点
- Number of Patients With Adverse Events
研究概览
简要总结
This trial will be a double-blind, randomized, placebo-controlled, safety, tolerability and efficacy trial of SAN007 (5% East Indian sandalwood oil in a cream formulation) treatment regimen when administered daily for up to 28 days to patients at least 18 years of age, with atopic dermatitis.
详细描述
Subjects will enter the Screening Period once the informed consent/ascent and photographic consent process has been completed. Subjects with a total body surface area (BSA) of ≥2% and ≤ 15% atopic dermatitis involvement, in the treatable areas, and who meet all of the inclusion and none of the exclusion criteria will be enrolled.
Once subject eligibility is confirmed and the screening procedures completed, the subject will start the Treatment Period of the study. All enrolled subjects will receive either 5% SAN007 cream or placebo cream (randomized in a 2:1 ratio) OR 10% SAN007 cream or placebo cream (randomized in a 2:1 ratio) with the first dose applied at Visit 1 Baseline. Subjects will be instructed on how to apply the study medication twice daily for 28 days. Subjects will return to the clinic on Study Days 7,14 and 28 for study-related assessments. Subjects will receive a telephone contact from the site, on Study Days 21 and 35.
Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.
In addition, cutaneous tolerability will be evaluated at each visit. Tolerability evaluation will be based on subjects reporting discomfort during or immediately following application of SAN007. This will also be recorded as an AE. The study exclusion areas are not to be included in this evaluation.
Efficacy will be assessed at each study visit through the completion of the IGA, EASI and BSA calculation.
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
- Double (Participant, Investigator)
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
- •Subjects will be included in the trial if they meet all of the following criteria:
- •Are at least 18 years of age
- •Have atopic dermatitis, as determined by an EASI score of ≥5 and ≤50 (Hanifin, 2001)
- •Total treatment area(s) of atopic dermatitis involvement ≥2% and ≤15% today surface area (BSA).
- •Have atopic dermatitis that has been clinically stable for ≥ 30-days prior to the Screening Visit.
- •Are able to obtain written informed consent/ascent in a manner approved by the Institutional Review Board and comply with the requirements of the study.
- •Are willing to refrain from using any lotions, moisturizer, cleansers, cosmetics or creams, other than those issued as part of the study, on the target treatment areas during the treatment period.
- •Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
- •Are willing to refrain from exposure to artificial ultraviolet radiation for the duration of the study.
- •Are willing to cover target treatment areas to avoid exposure to natural ultraviolet radiation for the duration of the study.
- •If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study. i.e. barrier method, hormone or intrauterine device.
- •Are willing to avoid participation in any other interventional clinical trial for the duration of this study.
- •Are willing to refrain from treating areas that are not in the defined treatment area(s), which will be excluded from the IGA assessments and BSA calculation. These areas are as follows: head, neck, soles of feet, palms of hands, axillae, or intertriginous areas.
排除标准
- •Subjects will be excluded from the trial if they meet any of the following criteria:
- •Have a sibling or immediate family member already participating in this trial.
- •Currently requires and/or, in the 30 days prior to Screening, has required topical use of a medium or high potency steroid (i.e. >1%)
- •Atopic dermatitis that, in the opinion of the investigator, is likely to stem from an allergic reaction. (i.e. contact dermatitis)
- •Have <2% or >15% total BSA of atopic dermatitis involvement in the target treatment area(s).
- •Have participated in any interventional clinical trial in the previous 30 days to the screening visit.
- •Have a known sensitivity to any of the constituents of the test product including sensitivities to sandalwood oil, fragrances or any member of the Compositae family of vascular plants (e.g., sunflowers, daisies, dahlias, etc.).
- •Have received phototherapy within the 60 days prior to Screening.
- •Have received any systemic medication for atopic dermatitis in the past 2 months that would interfere with the evaluation of atopic dermatitis (excluding antihistamines or leukotriene inhibitors).
- •Have a present condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- •Are pregnant, breast-feeding or plan to become pregnant at any point for the duration of the trial.
- •Are not willing to practice an approved form of birth control while on the study drug for the duration of the trial. i.e. barrier method, hormone or intrauterine device.
- •Have been treated, with prescription medication for atopic dermatitis, within 60 days prior to the Baseline visit.
- •Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years,or any other confounding skin condition.
- •Have undergone treatments with topical atopic dermatitis drug products, other than retinoids or corticosteroids, within 14 days prior to the Baseline Visit, and for therapy containing corticosteroids or retinoids within 28 days prior to Baseline Visit.
- •Have open sores or open lesions in the treatment area(s).
- •Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past 2 years.
- •Require greater than 2.0 mg/day inhaled or intranasal corticosteroids.
- •Have an active infection of any kind at Visit 1 (Baseline)
- •Have an occupation that requires ≥50% of time be spent outdoors, where prolonged exposure to ultraviolet radiation is unavoidable.
研究组 & 干预措施
SAN007 5% cream
A cream containing 5% East Indian sandalwood oil (EISO).
干预措施: SAN007 5% cream (Drug)
Placebo cream
The vehicle cream
干预措施: Placebo (Drug)
SAN007 10% cream
A cream containing 10% East Indian Sandalwood Oil (EISO).
干预措施: SAN007 10% cream (Drug)
结局指标
主要结局
Number of Patients With Adverse Events
时间窗: 28 days
Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.
次要结局
- Percentage of Subjects Who Have a ≥ 50% Reduction in the Eczema Area and Severity Index (EASI) Score(28 days)