A Randomized, Double-Blind, Vehicle-Controlled, Within-Subject, Comparison Study of the Safety, Tolerability, And Effectiveness of A-101 Topical Solution in Subjects With Seborrheic Keratosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Mean Change in Physician Lesion Assessment Scale
研究概览
简要总结
Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on the back of subjects.
详细描述
The main objective of this study is to evaluate the safety, effectiveness and tolerability of three concentrations of A-101 25%, 32.5%, and 40%, when applied to individual seborrheic keratosis target lesions on the back compared with a matching A-101 vehicle.
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
- •Is at least 18 years of age
- •Has a clinical diagnosis of stable clinically typical seborrheic keratosis
- •Has at least 4 appropriate seborrheic keratosis target lesions on the back
- •If subject is a women of childbearing potential, she must have a negative urine pregnancy test and must agree to use an active form of birth control for the duration of the study
- •Is non-pregnant and non-lactating
- •Is in good general health and free of any disease state or physical condition which, in the investigator's opinion, might impair evaluation of any target lesion or which exposes the subject to an unacceptable risk by study participation
- •Is willing and able to follow all study instructions and to attend all study visits
- •Is able to comprehend and willing to sign an Informed Consent Form (ICF).
排除标准
- •Has clinically atypical and/or rapidly growing seborrheic keratosis lesions
- •Has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat)
- •Has used any of the following systemic therapies within the specified period prior to Visit 1:
- •Retinoids; 180 days
- •Glucocorticosteroids; 28 days
- •Anti-metabolites (e.g., methotrexate); 28 days
- •Has used any of the following topical therapies on the treatment area within the specified period prior to Visit 1:
- •Retinoids; 90 days
- •Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days
- •Glucocorticosteroids or antibiotics; 14 days
- •Moisturizers/emollients, sunscreens; 12 hours
- •Has had any LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy (PDT)) or other energy based therapy on the treatment area within 180 days prior to Visit 1
- •Has a history of keloid formation or hypertrophic scarring
- •Has a current systemic malignancy
- •Has a history of, within the 180 days prior to Visit 1, or has a current cutaneous malignancy on the treatment area
- •Has a current pre-malignancy (e.g., actinic keratosis) on the treatment area
- •Has had body art (e.g., tattoos, piercing, sculpting, etc.) or any other invasive, non-therapeutic procedure performed on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
- •Has excessive tan on the treatment area that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
- •Has experienced a sunburn on the treatment area within the previous 4 weeks
- •Has a history of sensitivity to any of the ingredients in the study medications
- •Has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, tattoos, excessive hair, open wounds on the back) that, in the opinion of the investigator, might put the subject at undue risk or interfere with the study conduct or evaluations
- •Has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.
研究组 & 干预措施
A-101 25%
Low dose group
干预措施: A-101 25% (Drug)
A-101 32.5%
Mid Dose Group
干预措施: A-101 32.5% (Drug)
A-101 40%
High Dose Group
干预措施: A-101 40% (Drug)
A-101 Vehicle
Placebo group
干预措施: A-101 Vehicle (Drug)
结局指标
主要结局
Mean Change in Physician Lesion Assessment Scale
时间窗: Visit 2 to visit 9 (78 days)
Mean Change in Score on the Physician Lesion Assessment Scale (PLA) of each Target Lesion. The PLAS is a four point scale from 0-3 with 0 being clear and 3 being the worst lesion. The primary effectiveness will consist of the mean change from Visit 2 to Visit 9 in PLA performed using Analysis of Covariance (ANCOVA) with Visit 2 PLAS as the covariate. Comparisons between vehicle and each active treatment group will be performed within the model using least-squares means and the common error term.
次要结局
- Subject's Self Assessment Scale(Visit 9 (Day 78))