Assessment of the Irritation and Sensitization Potential of a Selegiline Transdermal Delivery System (6 mg/24 h) as Compared to a Reference Product (EMSAM® 6 mg/24 h)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 232
- 试验地点
- 3
- 主要终点
- Assessment of irritation
研究概览
简要总结
The two products used in this study are transdermal patches that contain selegiline. The test drug is the Selegiline Transdermal Delivery System (TDS). The comparator drug is the EMSAM® TDS.
The purpose of this research study is to compare how the skin tolerates the test TDS and the comparator TDS. The study will evaluate and compare skin irritation and possible allergic-type skin reactions (sensitization) caused by the two products.
The comparison will be based on how the skin responds to repeated applications of each TDS. This includes the assessment of skin irritation during the Induction Period and the evaluation of possible allergic or sensitization reactions after the Challenge Period. In addition, the adhesion of each patch (how well the patch sticks to the skin over time) will be regularly checked, as this is important for both product performance and skin safety.
详细描述
This is a multi-center, evaluator-blinded, randomized phase 1 study evaluating skin irritation and skin sensitization of Selegiline transdermal system in comparison to EMSAM® transdermal patch in healthy volunteers. The study will consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.
Trained study staff will examine the patch application sites at scheduled time points and will score any skin reactions using standardized assessment scales. In addition, photographs of the patch application site will be taken to document adhesion status while the patch is being worn.
Furthermore, the overall safety of the test product will be compared with that of the comparator product by monitoring and recording any adverse events, side effects, or discomfort experienced during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female non-smoking subject.
- •Lack of clinically significant abnormalities in health assessments performed at screening as deemed by the Investigator (or designee)
- •BMI within the range (including the borders) of 18.5 to 29.9 kg/m2
排除标准
- •Medical history or presence of ANY current dermatological condition such as atopy, psoriasis, eczema, chronic or atopic dermatitis, vitiligo, or urticaria which, in the opinion of the Investigator, would compromise the safety of the subject or the integrity of the study
- •Medical history or current evidence, as determined by the Investigator, of chronic infectious disease, system disorders, seizure disorders, or cardiovascular disorders (especially hypertension or family history of sudden cardiac death)
- •Medical history of a condition that would significantly influence the immune response (e.g., primary or acquired immunodeficiencies such as HIV or AIDS; allergic diseases such as anaphylaxis, asthma, or generalized drug reaction; neoplasms such as lymphoma or leukemia; rheumatoid arthritis; or systemic lupus erythematosus)
- •Clinically significant illness within 4 weeks before screening visit
研究组 & 干预措施
1/2 Selegiline TDS on left arm, 1/2 EMSAM® TDS on right arm
干预措施: Selegiline Transdermal Delivery System (Drug)
1/2 Selegiline TDS on right arm, 1/2 EMSAM® TDS on left arm
干预措施: Selegiline Transdermal Delivery System (Drug)
结局指标
主要结局
Assessment of irritation
时间窗: From enrollment through the induction, challenge and potential rechallenge phases, up to 15 weeks.
Mean Irritation Score (MIS)
Assessment of sensitization
时间窗: From enrollment through induction, challenge and potential re-challenge phase, up to 15 weeks.
Number and proportion of subjects sensitized and potentially sensitized to each TDS unit
次要结局
未报告次要终点