Evaluation of Dermal Acceptability and Comedogenic and Acnegenic Potential of a Cosmetic Product (DACP)
Clinical Evaluation of Dermal Acceptability and the Comedogenic and Acnegenic Potential of a Cosmetic Product
This is a single-center, single-blind clinical study designed to evaluate the dermatological safety of a cosmetic product and to demonstrate the absence of comedogenic and acnegenic potential.
A total of 33 female participants, aged 18 to 60 years, with oily and acne-prone skin will be enrolled. Participants will use the investigational product for 28 days under normal conditions of use.
Dermatological safety, skin tolerability, and the absence of comedogenic and acnegenic effects will be assessed throughout the study period by clinical evaluations conducted according to the study protocol.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Layane Melody Da Silva Reis Cavalcante
- 电话号码:+55 (11) 4507-2183
- 邮箱:layane.reis@brainfarma.ind.br
学习地点
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São Paulo
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Osasco、São Paulo、巴西、06023-070
- 招聘中
- Grupo Medcin
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接触:
- Camila Canale
- 电话号码:+55 (11) 98343 6952
- 邮箱:camila.canale.ext@medcin.com.br
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首席研究员:
- Sergio Schalka
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Female participants aged 18 to 45 years.
- Participants with oily and acne-prone skin.
- Intact skin in the area intended for application and assessment of the investigational product.
- Willingness to comply with all study procedures and attend scheduled visits and assessments.
- Ability to understand the study requirements, provide written informed consent, and sign the Informed Consent Form (ICF).
Exclusion Criteria:
- Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study.
- Use of anti-inflammatory, immunosuppressive, or antihistamine medications within 3 weeks prior to screening.
- Skin conditions or marks in the study area that may interfere with the evaluation of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
- History of atopic conditions or allergy to cosmetic products.
- Active skin diseases and/or lesions in the assessment area or elsewhere on the body.
- Immunosuppression due to medication use or active disease.
- Uncontrolled endocrine disorders.
- Relevant medical history or current evidence of alcohol or substance abuse.
- Known history or suspected intolerance to products of the same category as the investigational product.
- Intense sun exposure within 15 days prior to assessment.
- Aesthetic or dermatological treatments within 4 weeks prior to assessment.
- Any other condition that, in the investigator's opinion, may interfere with study participation, study evaluations, or justify exclusion from the study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Cosmetic Product Group
Female participants aged 18 to 60 years with oily and acne-prone skin will use the investigational cosmetic product for 28 days.
Dermatological safety, skin tolerability, and the absence of comedogenic and acnegenic potential will be evaluated throughout the study period.
|
Blancy Pro is a cosmetic product intended for daily use in individuals with oily and acne-prone skin.
Participants will use the product for 28 days under normal conditions of use.
Dermatological safety and the absence of comedogenic and acnegenic potential will be evaluated through clinical assessments.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Dermatological Safety and Skin Tolerability
大体时间:Day 28
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Evaluation of the absence of skin irritation risk and assessment of participant-reported discomfort sensations under real-world conditions of use through dermatological clinical evaluations in female participants with oily and acne-prone skin.
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Day 28
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Absence of Comedogenic and Acnegenic Potential
大体时间:Baseline (Day 0) to Day 28
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Evaluation of the absence of comedogenic and acnegenic potential of the investigational cosmetic product under normal conditions of use in participants with oily and acne-prone skin through dermatological clinical assessments.
|
Baseline (Day 0) to Day 28
|
合作者和调查者
调查人员
- 首席研究员:Sergio Schalka、Grupo Medcin
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 26-0161-04
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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